| 2025-07-25 |
Class I
|
Ongoing |
Z-2567-2025 |
Medline medical convenience kits labeled as: 1. NEWBORN RESUSCITATION KIT, Kit Number ACC010381C; 2. DRAWER 5 - POS… |
— |
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Flexicare BritePro Solo Fiber Optic Laryngoscope Handles d… |
| 2025-07-25 |
Class I
|
Ongoing |
Z-2566-2025 |
Medline medical convenience kits labeled as: 1. ADULT INTUBATION TRAY, Kit Number ACC010369B; 2. ADULT ICU INTUBATI… |
— |
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Flexicare BritePro Solo Fiber Optic Laryngoscope Handles d… |
| 2025-07-23 |
Class II
|
Ongoing |
Z-2479-2025 |
Medline Kits containing BD SureStep Foley Tray Systems: SKU/Description: CDS984076J GYN ROBOTIC DYNJG001004A LAVH… |
— |
Kits contain SureStep Foley Tray Systems recalled by BD that include incorrect product information insert sheets. If a mislabeled tray is used, patient risk ran… |
| 2025-07-14 |
Class I
|
Ongoing |
Z-2460-2025 |
Medline ReNewal Reprocessed St. Jude Medical Response and Supreme Diagnostic Electrophysiology Catheter Models 401150RH… |
— |
Specific lots of reprocessed electrophysiology catheters may contain small residual particulates. |
| 2025-07-08 |
Class II
|
Ongoing |
Z-2452-2025 |
The Medline General Surgery Tray is customized to meet requirements of the hospitals and health care professionals utili… |
— |
Affected kits contain recalled Stryker Color Cuff Sterile Disposable Tourniquet Cuffs. Stryker Instruments initiated this recall due to a potential manufacturin… |
| 2025-06-16 |
Class II
|
Ongoing |
Z-2199-2025 |
SwabFlush Prefilled Syringe with ICU Medical SwabCaps, 10mL Model no. EMZE010301 |
— |
SwabFlush syringes are affected by the ICU Medical recall of their SwabCap Disinfecting Cap due to a manufacturing issue which affects the seal between the foil… |
| 2025-06-12 |
Class II
|
Ongoing |
Z-2156-2025 |
Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: C-SECTION PREP, REF DYNJ32702B |
— |
Affected convenience kits contain BD ChloraPrep Clear - 1 mL Applicators, which were recalled by BD due to potential to exhibit an open seal on its packaging. T… |
| 2025-06-12 |
Class II
|
Ongoing |
Z-2155-2025 |
Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: 1) BLOOD CULTURE KIT, REF DYND… |
— |
Affected convenience kits contain BD ChloraPrep Clear - 1 mL Applicators, which were recalled by BD due to potential to exhibit an open seal on its packaging. T… |
| 2025-06-12 |
Class II
|
Ongoing |
Z-2154-2025 |
Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: IV START KIT LAB DRAW-SH, REF … |
— |
Affected convenience kits contain BD ChloraPrep Clear - 1 mL Applicators, which were recalled by BD due to potential to exhibit an open seal on its packaging. T… |
| 2025-06-12 |
Class II
|
Ongoing |
Z-2153-2025 |
Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: LABOR TRIAGE KIT, REF DYKM1564 |
— |
Affected convenience kits contain BD ChloraPrep Clear - 1 mL Applicators, which were recalled by BD due to potential to exhibit an open seal on its packaging. T… |
| 2025-05-23 |
Class II
|
Ongoing |
Z-2045-2025 |
Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN. labeled as: RETINAL PACK… |
— |
Medline Industries, LP. is issuing a recall for specific Medline kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN which was identified … |
| 2025-05-23 |
Class II
|
Ongoing |
Z-2044-2025 |
Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN. labeled as: IV START BOX… |
— |
Medline Industries, LP. is issuing a recall for specific Medline kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN which was identified … |
| 2025-05-23 |
Class II
|
Ongoing |
Z-2043-2025 |
Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN. labeled as: 1) CC DRAW… |
— |
Medline Industries, LP. is issuing a recall for specific Medline kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN which was identified … |
| 2025-05-15 |
Class II
|
Ongoing |
Z-1995-2025 |
Medline UMBILICAL TRAY W/3.5&5FR CATH, REF UVT1250 |
— |
There is a possible packaging defect impacting the outer Tyvec pouch that protects the sterile product. |
| 2025-04-22 |
Class I
|
Ongoing |
Z-1811-2025 |
Medline Kits containing Codman Disposable Perforator 14 mm: 1. CRANI ACCESSORY PACK SKU DYNJ59270 2. CRANI PA… |
— |
Affected kits contain recalled Integra Lifesciences Codman Disposable Perforators due to inadequate welds on specific lots. Perforators with inadequate welds ma… |
| 2025-04-22 |
Class I
|
Ongoing |
Z-1810-2025 |
Medline Kits containing Codman Disposable Perforator 14 mm: CRANIOTOMY, SKU DYNJ35349C |
— |
Affected kits contain recalled Integra Lifesciences Codman Disposable Perforators due to inadequate welds on specific lots. Perforators with inadequate welds ma… |
| 2025-04-22 |
Class I
|
Ongoing |
Z-1809-2025 |
Medline Kits containing Codman Disposable Perforator 14 mm: 1. CRANI ADD A PACK, SKU DYNJ30926O 2. CRANIOTOMY, SKU C… |
— |
Affected kits contain recalled Integra Lifesciences Codman Disposable Perforators due to inadequate welds on specific lots. Perforators with inadequate welds ma… |
| 2025-04-09 |
Class II
|
Ongoing |
Z-1766-2025 |
Centurion Sterile Weitlaner Retractor 3 x 4 Prong, Reorder: I68395 |
— |
Three is the potential for the retractors to puncture through the sterile packaging. |
| 2025-04-09 |
Class II
|
Ongoing |
Z-1765-2025 |
Centurion Sterile Weitlaner Retractor, Reorder: 67315 |
— |
Three is the potential for the retractors to puncture through the sterile packaging. |
| 2025-03-24 |
Class II
|
Ongoing |
Z-1719-2025 |
Meridian Bioscience ImmunoCard STAT! Crypto/Giardia Test Kits, Model Number 750830 |
— |
A single lot of the ImmunoCard STAT! Crypto/Giardia Test Kit was inadvertently stored in Medline warehouses at temperatures outside of the labeled storage requi… |
| 2025-03-19 |
Class II
|
Ongoing |
Z-1714-2025 |
Medline procedure kits, labeled as: HAND, REF DYNJ902002J |
— |
It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle openin… |
| 2025-03-19 |
Class II
|
Ongoing |
Z-1713-2025 |
Medline procedure kits, labeled as: OL OCULAR, REF DYNJ906183K |
— |
It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle openin… |
| 2025-03-19 |
Class II
|
Ongoing |
Z-1712-2025 |
Medline procedure kits, labeled as: REDDY JOINT BATH, REF MMJB001A |
— |
It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle openin… |
| 2025-03-19 |
Class II
|
Ongoing |
Z-1711-2025 |
Medline procedure kits, labeled as: 1) WOUND CARE TRAY, REF DYNDA1412A; 2) LACERATION TRAY, REF DYNDL1263A. |
— |
It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle openin… |
| 2025-03-19 |
Class II
|
Ongoing |
Z-1710-2025 |
Medline procedure kits, labeled as: PLASTICS SUTURE TRAY, REF SUT13535 |
— |
It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle openin… |
| 2025-03-19 |
Class II
|
Ongoing |
Z-1709-2025 |
Medline procedure kits, labeled as: 1) STERILE PREP KIT, REF DYNDA1359A; 2) STRL EK SINGLE PACK, REF DYNDA1360B; … |
— |
It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle openin… |
| 2025-03-19 |
Class II
|
Ongoing |
Z-1708-2025 |
Medline procedure kits, labeled as: NON STERILE I&D KIT, REF DYKM1438 |
— |
It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle openin… |
| 2025-03-19 |
Class II
|
Ongoing |
Z-1707-2025 |
Medline procedure kits, labeled as: T AND A PACK -LF, REF DYNJ85792 |
— |
It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle openin… |
| 2025-03-19 |
Class II
|
Ongoing |
Z-1706-2025 |
Medline Sterile 0.9% Normal Saline, USP, 100mL, REF RDI30296 |
— |
It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle openin… |
| 2025-03-19 |
Class II
|
Ongoing |
Z-1705-2025 |
Medline Sterile Water, USP, 100mL, REF RDI30295 |
— |
It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle openin… |
| 2025-03-05 |
Class II
|
Ongoing |
Z-1549-2025 |
MEDLINE ReNewal ENT Coblator II PROcise mAx,W/ Integrated Cable Suction & Saline (Blue), Item Number REF EICA88980R |
— |
Medline ReNewal has identified that the drip chambers of affected devices may disconnect from the saline line tubing when under tension. |
| 2025-03-05 |
Class II
|
Ongoing |
Z-1548-2025 |
MEDLINE ReNewal ENT Coblator II PROcise XP Wand,w/Integrated Cable Suction & Saline (Blue), Item Number REF EICA88720R |
— |
Medline ReNewal has identified that the drip chambers of affected devices may disconnect from the saline line tubing when under tension. |
| 2025-03-05 |
Class II
|
Ongoing |
Z-1547-2025 |
MEDLINE ReNewal Coblator II ENT Evac 70 Xtra HP,w/Integrated Cable (Blue/Grey), Number REF EICA58740R |
— |
Medline ReNewal has identified that the drip chambers of affected devices may disconnect from the saline line tubing when under tension. |
| 2025-03-05 |
Class II
|
Ongoing |
Z-1546-2025 |
MEDLINE ReNewal Coblator II Evac 70 Xtra Plasma Wand,w/Integrated Saline Line & Integrated Cable, Item Number REF EICA5… |
— |
Medline ReNewal has identified that the drip chambers of affected devices may disconnect from the saline line tubing when under tension. |
| 2025-03-03 |
Class II
|
Ongoing |
Z-1619-2025 |
Medline Convenience kits used for various procedures: 1) ARTHROSCOPIE DU GENOU-LF, Model Number: DYNJ40229A; 2) ARTHR… |
— |
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits. |
| 2025-03-03 |
Class II
|
Ongoing |
Z-1618-2025 |
Refer to RES |
— |
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits. |
| 2025-03-03 |
Class II
|
Ongoing |
Z-1617-2025 |
Medline Convenience kits used for various procedures: 1) BASIC CATARACT, Model Number: DYNJ41097A; 2) PK EYE, Model N… |
— |
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits. |
| 2025-03-03 |
Class II
|
Ongoing |
Z-1616-2025 |
Medline Convenience kits used for various procedures: 1) UTHET TYLER OB PACK, Model Number: DYNJ68673; 2) D AND C PAC… |
— |
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits. |
| 2025-03-03 |
Class II
|
Ongoing |
Z-1615-2025 |
Medline Convenience kits used for various procedures: 1) PERI GYN PACK, Model Number: DYNJ80786; 2) D & C HYSTEROSCOP… |
— |
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits. |
| 2025-03-03 |
Class II
|
Ongoing |
Z-1614-2025 |
Medline Convenience kits used for various procedures: 1) ED CRASH C-SECTION TRAY, Model Number: MNS13635A; 2) C-SECTI… |
— |
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits. |
| 2025-03-03 |
Class II
|
Ongoing |
Z-1613-2025 |
Medline Convenience kits used for various procedures: 1) STANDARD D&C, Model Number: DYNJ69733; 2) NHS - LAP BOWEL GN… |
— |
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits. |
| 2025-03-03 |
Class II
|
Ongoing |
Z-1612-2025 |
Medline Convenience kits used for various procedures: 1) CW PERI GYN, Model Number: DYNJ80807B |
— |
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits. |
| 2025-03-03 |
Class II
|
Ongoing |
Z-1611-2025 |
Medline Convenience kits used for various procedures: 1) LABOR AND DELIVERY PACK-LF, Model Number: DYNJ26971L; 2) VAG… |
— |
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits. |
| 2025-03-03 |
Class II
|
Ongoing |
Z-1610-2025 |
Medline Convenience kits used for various procedures: 1) NEURO PACK WRO-LF, Model Number: DYNJ41856C; 2) STIM IMPLANT… |
— |
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits. |
| 2025-03-03 |
Class II
|
Ongoing |
Z-1609-2025 |
Medline Convenience kits used for various procedures: 1) HERNIA REPAIR TOTE, Model Number: DYNJ908337C |
— |
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits. |
| 2025-03-03 |
Class II
|
Ongoing |
Z-1608-2025 |
Medline Convenience kits used for various procedures: 1) UNIVERSAL DRAPE PACK, Model Number: DYNJCD0239 |
— |
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits. |
| 2025-03-03 |
Class II
|
Ongoing |
Z-1607-2025 |
Medline Convenience kits used for various procedures: 1) CSTM PACEMAKER DRAPE PACK, Model Number: DYNJCD0339 |
— |
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits. |
| 2025-03-03 |
Class II
|
Ongoing |
Z-1606-2025 |
Medline Convenience kits used for various procedures: 1) SKIN LESION SET, Model Number: MNS6270 |
— |
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits. |
| 2025-03-03 |
Class II
|
Ongoing |
Z-1605-2025 |
Medline Convenience kits used for various procedures: 1) NAIL PACK, Model Number: SUT15830A; |
— |
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits. |
| 2025-03-03 |
Class II
|
Ongoing |
Z-1604-2025 |
Medline Convenience kits used for various procedures: 1) IV PACK SOUTH, Model Number: DYNJ88422 |
— |
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits. |
| 2025-03-03 |
Class II
|
Ongoing |
Z-1603-2025 |
Medline Convenience kits used for various procedures: 1) PRECIP TRAY, Model Number: MNS12590 |
— |
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits. |
| 2025-03-03 |
Class II
|
Ongoing |
Z-1602-2025 |
Refer to RES |
— |
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits. |
| 2025-03-03 |
Class II
|
Ongoing |
Z-1601-2025 |
Medline Convenience kits used for various procedures: 1) MINOR BASIN -SMH, Model Number: DYNJ907733B |
— |
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits. |
| 2025-03-03 |
Class II
|
Ongoing |
Z-1600-2025 |
Medline Convenience kits used for various procedures: 1) OCULOPLASTIC PICK PACK, Model Number: DYNJ43914B; 2) PLASTIC… |
— |
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits. |
| 2025-03-03 |
Class II
|
Ongoing |
Z-1599-2025 |
Medline Convenience kits used for various procedures: 1) T&A ENDO PACK, Model Number: DYNJ59620A; 2) TRAY ADD A CATH … |
— |
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits. |
| 2025-03-03 |
Class II
|
Ongoing |
Z-1598-2025 |
Refer to RES |
— |
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits. |
| 2025-03-03 |
Class II
|
Ongoing |
Z-1597-2025 |
Medline Convenience kits used for various procedures: 1) T A PACK, Model Number: DYNJ67791A; 2) NASAL PACK, Model N… |
— |
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits. |
| 2025-03-03 |
Class II
|
Ongoing |
Z-1596-2025 |
Medline Convenience kits used for various procedures: 1) RHINOPLASTY PACK, Model Number: DYNJ27333F |
— |
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits. |
| 2025-03-03 |
Class II
|
Ongoing |
Z-1595-2025 |
Medline Convenience kits used for various procedures: 1) DENTAL PACK-LF, Model Number: DYNJ84880; 2) DENTAL PACK, Mod… |
— |
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits. |
| 2025-03-03 |
Class II
|
Ongoing |
Z-1594-2025 |
Medline Convenience kits used for various procedures: 1) LARGE BIOPSY PACK NTX, Model Number: DYNJ68393A; 2) SOFT TIS… |
— |
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits. |
| 2025-03-03 |
Class II
|
Ongoing |
Z-1593-2025 |
Medline Convenience kits used for various procedures: 1) LINE INSERTION PACK, Model Number: DYNJ44949C; 2) PICC LINE … |
— |
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits. |
| 2025-03-03 |
Class II
|
Ongoing |
Z-1592-2025 |
Medline Convenience kits used for various procedures: 1) DR. KHAN CABG ADDS PACK, Model Number: DYNJ59310D; 2) CARDIA… |
— |
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits. |
| 2025-03-03 |
Class II
|
Ongoing |
Z-1591-2025 |
Medline Convenience kits used for various procedures: 1) ANGIOGRAPHY DRAPE PACK, Model Number: HCP075G; 2) ENSEMBLE C… |
— |
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits. |
| 2025-03-03 |
Class II
|
Ongoing |
Z-1590-2025 |
Medline Convenience kits used for various procedures: 1) ANGIO CONSOLIDATED PACK, Model Number: DYNJHTCAD1; 2) ANGIOG… |
— |
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits. |
| 2025-03-03 |
Class II
|
Ongoing |
Z-1589-2025 |
Medline Convenience kits used for various procedures: 1) CUSTOM BLOCK KEMP PACK-LF, Model Number: DYNJ0371999G; |
— |
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits. |
| 2025-03-03 |
Class II
|
Ongoing |
Z-1588-2025 |
Medline Convenience kits used for various procedures: 1) PAIN PACK, Model Number: DYNJ67577A; 2) PAIN TRIAL PACK, Mod… |
— |
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits. |
| 2025-03-03 |
Class II
|
Ongoing |
Z-1587-2025 |
Medline Convenience kits used for various procedures: 1) RHINOPLASTY PACK, Model Number: DYNJ84116A |
— |
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits. |
| 2025-03-03 |
Class II
|
Ongoing |
Z-1586-2025 |
Medline Convenience kits used for various procedures: 1) INTUBATION TRAY, Model Number: MNS10395; |
— |
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits. |
| 2025-02-24 |
Class I
|
Ongoing |
Z-1505-2025 |
Medline medical convenience kits labeled as: 1) NEONATAL INTUBATION TRAY, REF ACC010371C; 2) NEWBORN RESUSCITATION … |
— |
Specific Medline Kits were manufactured using Intubation ORAL/NASAL Endotracheal Tubes which were subsequently recalled by Smiths Medical. |
| 2025-02-21 |
Class I
|
Ongoing |
Z-1459-2025 |
Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: CPB ADJUNCT PACK, DR. C… |
— |
Medical convenience kits containing Medtronic Aortic Root Cannula are being recalled due to the potential excess material in the male lures on the aortic cannul… |
| 2025-02-21 |
Class I
|
Ongoing |
Z-1458-2025 |
Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: HEART BASIN PACK-LF |
— |
Medical convenience kits containing Medtronic Aortic Root Cannula are being recalled due to the potential excess material in the male lures on the aortic cannul… |
| 2025-02-21 |
Class I
|
Ongoing |
Z-1457-2025 |
Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: TOL DR R PACK |
— |
Medical convenience kits containing Medtronic Aortic Root Cannula are being recalled due to the potential excess material in the male lures on the aortic cannul… |
| 2025-02-21 |
Class I
|
Ongoing |
Z-1456-2025 |
Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: CABG OPNHRT S HSP, CARD… |
— |
Medline medical procedure kits, containing Medtronic Aortic Root Cannula |
| 2025-02-19 |
Class II
|
Ongoing |
Z-1531-2025 |
Wayson Hydrocolloid Models: 1) MJ BANDAGE HYDROCOLLOID HEEL OVAL 6CT, Model Number: MJ18004V2; 2) MJ BANDAGE HYDROCOL… |
— |
There is a potential for the sterility of the device to be compromised. |
| 2025-02-19 |
Class II
|
Ongoing |
Z-1530-2025 |
Wayson Hydrocolloid Models: 1) Model Number: CUR5103, DBD-BNDG,WTRPRF,HYDRCLLD,CLR,2.36X3.93", 2) Model Number: MJ1800… |
— |
There is a potential for the sterility of the device to be compromised. |
| 2025-02-13 |
Class II
|
Ongoing |
Z-1370-2025 |
Proxima Drape labeled as ORTHO TRAUMA CDS, TOTAL KNEE AUX PACK, TOTAL HIP PACK, TOTAL HIP, TOTAL KNEE, SPINE. Sterile su… |
— |
Potential breach in pouch packaging which could lead to loss of sterility. |
| 2025-02-13 |
Class II
|
Ongoing |
Z-1369-2025 |
Proxima Drape labeled as UNIVERSAL DAVINCI ROBOTIC P. Sterile surgical drape. |
— |
Potential breach in pouch packaging which could lead to loss of sterility. |
| 2025-02-13 |
Class II
|
Ongoing |
Z-1368-2025 |
Proxima Drape labeled as HEAD AND NECK OSIS, WILLIS SHOULDER PACK, EXTREMITY PACK-LF, TOTAL HIP PACK-LF, SHOULDER W/POUC… |
— |
Potential breach in pouch packaging which could lead to loss of sterility. |
| 2025-02-13 |
Class II
|
Ongoing |
Z-1367-2025 |
Proxima Drape labeled as FACE LIFT. Sterile surgical drape. |
— |
Potential breach in pouch packaging which could lead to loss of sterility. |
| 2025-02-13 |
Class II
|
Ongoing |
Z-1366-2025 |
Proxima Drape labeled as MINOR PACK and LAPAROSCOPY. Sterile surgical drape. |
— |
Potential breach in pouch packaging which could lead to loss of sterility. |
| 2025-02-13 |
Class II
|
Ongoing |
Z-1365-2025 |
Proxima Drape labeled as ENT-PLASTICS PACK. Sterile surgical drape. |
— |
Potential breach in pouch packaging which could lead to loss of sterility. |
| 2025-02-13 |
Class II
|
Ongoing |
Z-1364-2025 |
Proxima Drape labeled as PACK,BASIC,SIRUS,V,5/CS; PACK,BASIC IV,SIRUS,5/CS; PACK,SET UP,NO DRAPE,12/CS; PACK,SET UP,NO D… |
— |
Potential breach in pouch packaging which could lead to loss of sterility. |
| 2025-02-13 |
Class II
|
Ongoing |
Z-1363-2025 |
Proxima Drape labeled as DRAPE C-SECTION W/ WINDOW; SHEET, DRAPE, SPLIT, ST,10/CS; DRAPE,LAPROSCOPY,CHOLE,W/TROUGH,ST,8/… |
— |
Potential breach in pouch packaging which could lead to loss of sterility. |
| 2025-02-12 |
Class II
|
Ongoing |
Z-1431-2025 |
namic convenience kits labeled as: 1) MTS,4 VALVE,LFT,HRT,KIT-AHS-A*,NW, REF 60010468; 2) MTS,RIGHT HEART,KIT,W/TRA… |
— |
The female luer fittings on the Pressure Monitoring Lines (PMLs) were manufactured with excess material near the fluid pathway. |
| 2025-02-12 |
Class II
|
Ongoing |
Z-1430-2025 |
namic convenience kits labeled as: MTS,COLOR,PML,KIT,-,FRENCH HOSPITAL PG; medical convenience kit, REF 600605710 |
— |
The female luer fittings on the Pressure Monitoring Lines (PMLs) were manufactured with excess material near the fluid pathway. |
| 2025-02-12 |
Class II
|
Ongoing |
Z-1429-2025 |
namic convenience kits labeled as: KIT,ARTERIAL,60,(152CM),PG; medical convenience kit, REF 70036160 |
— |
The female luer fittings on the Pressure Monitoring Lines (PMLs) were manufactured with excess material near the fluid pathway. |
| 2025-02-12 |
Class II
|
Ongoing |
Z-1428-2025 |
namic convenience kits labeled as: PML,72,ADULT,FLL-MLL,-,OEM, REF 80641722; medical convenience kit |
— |
The female luer fittings on the Pressure Monitoring Lines (PMLs) were manufactured with excess material near the fluid pathway. |
| 2025-02-11 |
Class II
|
Ongoing |
Z-1465-2025 |
Medline procedure kits labeled as: 1) ACL ARTHROSCOPY PACK, Pack Number DYNJ55316G; 2) ARTERIOGRAM PACK, Pack Number … |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been… |
| 2025-02-11 |
Class II
|
Ongoing |
Z-1464-2025 |
Medline procedure kits labeled as: 1) ACOUSTIC NEUROMA PACK-LF, Pack Number DYNJ37741B; 2) ANGIOGRAPHY PACK, Pack N… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been… |
| 2025-02-11 |
Class II
|
Ongoing |
Z-1463-2025 |
Medline procedure kits labeled as: 1) ANGIOGRAPHY SPECIALS |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been… |
| 2025-02-11 |
Class II
|
Ongoing |
Z-1462-2025 |
Medline procedure kits labeled as: 1) BREAST PACK-LF, Pack Number DYNJ0956628O; 2) BREAST SURGERY FOAKS, Pack Numbe… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been… |
| 2025-02-11 |
Class II
|
Ongoing |
Z-1461-2025 |
Medline procedure kits labeled as: 1) BILLINGS CLINIC SC HEAD & NECK, Pack Number DYNJ33656C; 2) BLEPH/RHINO PACK, P… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been… |
| 2025-02-11 |
Class II
|
Ongoing |
Z-1453-2025 |
Medline procedure kits labeled as: 1) C SCOPE DISPOSABLE KIT, Pack Number 613034700, 2) C SCOPE DISPOSABLE KIT, Pac… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been… |
| 2025-02-11 |
Class II
|
Ongoing |
Z-1452-2025 |
Medline procedure kits labeled as: 1) ARTHROSCOPY PACK, Pack Number DYNJHS0101I; 2) ARTHROSCOPY PACK-LF, Pack Numbe… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been… |
| 2025-02-11 |
Class II
|
Ongoing |
Z-1451-2025 |
Medline procedure kits labeled as: 1) AOP/BASIC EYE PACK-LF, Pack Number DYNJ0589795V; 2) CATARACT CM-LF, Pack Numb… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been… |
| 2025-02-11 |
Class II
|
Ongoing |
Z-1450-2025 |
Medline procedure kits labeled as: 1) L S GYN PACK, Pack Number DYNJ65616C; 2) MAIN CYSTO, Pack Number DYNJ61371A; … |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been… |
| 2025-02-11 |
Class II
|
Ongoing |
Z-1449-2025 |
Medline procedure kits labeled as: 1) CSMC/ABDOMINAL HYST PACK-LF, Pack Number DYNJ0665086F; 2) MAJOR VAGINAL HARPE… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been… |
| 2025-02-11 |
Class II
|
Ongoing |
Z-1448-2025 |
Medline procedure kits labeled as: 1) C SECTION, Pack Number DYNJ57622; 2) C SECTION PACK, Pack Number DYNJ48483B; … |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been… |
| 2025-02-11 |
Class II
|
Ongoing |
Z-1447-2025 |
Medline procedure kits labeled as: 1) CLOVIS ROBOTIC-LF, Pack Number DYNJ61061D; 2) CSMC/GYN LAPAROSCOPIC PACK-LF, … |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been… |
| 2025-02-11 |
Class II
|
Ongoing |
Z-1446-2025 |
Medline procedure kits labeled as: 1) DELIVERY PACK, Pack Number DYNJ0923016; 2) DELIVERY PACK-LF, Pack Number DYNJ… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been… |
| 2025-02-11 |
Class II
|
Ongoing |
Z-1445-2025 |
Medline procedure kits labeled as: 1) LACERATION TRAY, Pack Number DYNJ17328B |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been… |
| 2025-02-11 |
Class II
|
Ongoing |
Z-1444-2025 |
Medline procedure kits labeled as: 1) A & A KNEE PACK-LF, Pack Number DYNJHS0136D; 2) ABD CLOSURE PACK, Pack Number D… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been… |
| 2025-02-11 |
Class II
|
Ongoing |
Z-1443-2025 |
Medline procedure kits labeled as: 1) CV NEONATAL PACK, Pack Number DYNJ67356 |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been… |
| 2025-02-11 |
Class II
|
Ongoing |
Z-1442-2025 |
Medline procedure kits labeled as: 1) GENERAL ENDOSCOPY PACK, Pack Number DYNJ44673G |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been… |
| 2025-02-11 |
Class II
|
Ongoing |
Z-1441-2025 |
Medline procedure kits labeled as: 1) ABLATION PACK, Pack Number DYNJ40629B; 2) ACH LAPAROSCOPIC GB PACK, Pack Numb… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been… |
| 2025-02-11 |
Class II
|
Ongoing |
Z-1440-2025 |
Medline procedure kits labeled as: 1) CT BIOPSY PACK, Pack Number DYNJ62734A; 2) E R C P PACK, Pack Number DYNJ4411… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been… |
| 2025-02-11 |
Class II
|
Ongoing |
Z-1439-2025 |
Medline procedure kits labeled as: 1) AV FISTULA PACK-LF, Pack Number DYNJ0826753O; 2) BARRINGTON ACCESSORY TTL KNE… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been… |
| 2025-02-11 |
Class II
|
Ongoing |
Z-1438-2025 |
Medline procedure kits labeled as: 1) AV FISTULA PACK, Pack Number DYNJ80088; 2) AV FISTULA PACK-LF, Pack Number DY… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been… |
| 2025-02-11 |
Class II
|
Ongoing |
Z-1437-2025 |
Medline procedure kits labeled as: 1) ANGIO DRAPE PACK (DRLUL)-LF, Pack Number DYNJ47718D; 2) ANGIO PACK, Pack Numb… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been… |
| 2025-02-11 |
Class II
|
Ongoing |
Z-1436-2025 |
Medline procedure kits labeled as: 1) ANGIO PACK, Pack Number DYNJ50624A; 2) ANGIO PACK, Pack Number DYNJ30501F; … |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been… |
| 2025-02-11 |
Class II
|
Ongoing |
Z-1435-2025 |
Medline procedure kits labeled as: 1) BILATERAL FACET TRAY, Pack Number DYNJRA0869A; 2) PAIN MANAGEMENT TRAY-LF, Pack… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been… |
| 2025-02-11 |
Class II
|
Ongoing |
Z-1394-2025 |
Medline procedure kits labeled as: 1) EYE PACK, Pack Number VAL038BSCLC |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been… |
| 2025-02-11 |
Class II
|
Ongoing |
Z-1393-2025 |
Medline procedure kits labeled as: 1) C SECTION, Pack Number DYNJ909098 |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been… |
| 2025-02-06 |
Class II
|
Ongoing |
Z-1460-2025 |
Medline ReNewal Reprocessed Livewire Steerable Electrophysiology Catheters, Medline Item Numbers: 401582R, 401904R, 4019… |
— |
Devices may have higher than expected amounts of bacterial endotoxin. |
| 2025-01-09 |
Class II
|
Ongoing |
Z-1183-2025 |
Medline Convenience Kits for Various Procedures: 1) CLOVIS RESP/INTUB DRAWER 2, Model Number ACC010809; 2) RESP/INTUBA… |
— |
Kits contain recalled components due to reports of reduced skin barrier wear time. This refers to a shorter duration that a skin barrier can effectively adhere … |
| 2025-01-09 |
Class II
|
Ongoing |
Z-1182-2025 |
Medline Convenience Kits for Various Procedures: 1) ADULT INTUBATION TRAY, Model Number DYNJAA254A; 2) ADULT MAIN DISP… |
— |
Kits contain recalled components due to reports of reduced skin barrier wear time. This refers to a shorter duration that a skin barrier can effectively adhere … |
| 2025-01-03 |
Class II
|
Ongoing |
Z-1173-2025 |
Medline RR-LIVER TRNS ACCESSORY PEDS, DUNJ63397; medical procedure convenience kit |
— |
Medline is recalling medical convenience kits which were assembled with specific Coloplast Foley catheters and Prostatic catheters which were subsequently recal… |
| 2024-12-31 |
Class I
|
Ongoing |
Z-0992-2025 |
Medline General Surgery Tray kits: 1) ARTERIAL LINE TRAY, Item Number ART600; 2) A LINE TRAY, Item Number ART690 |
— |
The catheter subassembly in the Integrated Arterial Catheter was manufactured with excess material on the catheter hub. |
| 2024-12-31 |
Class I
|
Ongoing |
Z-0991-2025 |
Medline General Surgery Tray Kits: 1) ARTERIAL LINE INSERTION KIT, Item Number ART1185B; 2) ARTERIAL LINE BUNDLE, I… |
— |
The catheter subassembly in the Integrated Arterial Catheter was manufactured with excess material on the catheter hub. |
| 2024-12-23 |
Class II
|
Ongoing |
Z-1049-2025 |
MEDLINE ARTERIAL LINE PACK, REF DYNJ65208B, medical convenience kit containing Infusion Catheter with Antimicrobial Hep… |
— |
Certain lots Sterile Infusion Catheters which were mislabeled as having a heparin coating were either distributed or manufactured into medical convenience kits … |
| 2024-12-23 |
Class II
|
Ongoing |
Z-1048-2025 |
CENTURION Infusion Catheter, 7F, 17cm (DO), Reorder MIC17F7; Infusion Catheter with Antimicrobial Heparin Coating. |
— |
Certain lots Sterile Infusion Catheters which were mislabeled as having a heparin coating were either distributed or manufactured into medical convenience kits … |
| 2024-12-16 |
Class I
|
Ongoing |
Z-0765-2025 |
Medline Fluid Delivery Set with Drip Chamber: 1) MTO,135,YELLOW,MICRO,SPK-MAIMONIDES, Item Number: 60130527; 2) MTO,… |
— |
Fluid Delivery Sets were incorrectly assembled with a white macro drip chamber instead of the required grey micro drip chamber. The macro drip chamber delivers … |
| 2024-12-16 |
Class I
|
Ongoing |
Z-0764-2025 |
Medline Fluid Delivery Set with Drip Chamber: 1) FDS,135,CHMN,W/F,MLL,RC(2),PG, Item Number 99000069; 2) FDS,135,NV,… |
— |
Fluid Delivery Sets were incorrectly assembled with a white macro drip chamber instead of the required grey micro drip chamber. The macro drip chamber delivers … |
| 2024-11-21 |
Class II
|
Ongoing |
Z-0794-2025 |
Medline custom medical procedure kits labeled as: 1) CRANI, REF CDS780089V; 2) CRANIOFACIAL CDS, REF CDS780102K; 3) … |
— |
Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin conta… |
| 2024-11-21 |
Class II
|
Ongoing |
Z-0793-2025 |
Medline custom medical procedure kits labeled as: 1) CERVICAL PACK-LF, REF DYNJ0867145G; 2) CERVICAL SPINE PACK HUM… |
— |
Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin conta… |
| 2024-11-21 |
Class II
|
Ongoing |
Z-0792-2025 |
Medline custom medical procedure kits labeled as: 1) ENSEMBLE RACHIS-LF, REF DYNJ47568B; 2) UROLOGY ROBOTIC, REF DY… |
— |
Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin conta… |
| 2024-11-21 |
Class II
|
Ongoing |
Z-0791-2025 |
Medline custom medical procedure kits labeled as: DEEP BRAIN STIMULATION PACK-LF |
— |
Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin conta… |
| 2024-11-21 |
Class II
|
Ongoing |
Z-0790-2025 |
See DocMan |
— |
Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin conta… |
| 2024-11-21 |
Class II
|
Ongoing |
Z-0789-2025 |
Medline custom medical procedure kits labeled as: 1) MICRODISECTOMY PACK, REF DYNJ80585A; 2) MICRODISECTOMY PACK, R… |
— |
Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin conta… |
| 2024-11-21 |
Class II
|
Ongoing |
Z-0788-2025 |
See DocMan |
— |
Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin conta… |
| 2024-11-21 |
Class II
|
Ongoing |
Z-0787-2025 |
Medline custom medical procedure kits labeled as: 1) NEURO BASIN PACK-LF, REF DYNJ39461J; 2) NEURO BASIN KIT, REF D… |
— |
Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin conta… |
| 2024-11-21 |
Class II
|
Ongoing |
Z-0786-2025 |
Medline custom medical procedure kits labeled as: 1) MEM MAXILLOFACIAL PACK-LF, REF DYNJ0660040R; 2) FREE FLAP PACK-… |
— |
Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin conta… |
| 2024-11-21 |
Class II
|
Ongoing |
Z-0785-2025 |
Medline custom medical procedure kits labeled as: 1) PANENDOSCOPY-LF, REF DYNJ36728C; 2) ENDOSCOPIC SINUS PACK, REF… |
— |
Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin conta… |
| 2024-11-21 |
Class II
|
Ongoing |
Z-0784-2025 |
Medline custom medical procedure kits labeled as: 1) ENDOSCOPIC SKULL BASE, REF DYNJ58648B; 2) ENDOSCOPIC SKULL BAS… |
— |
Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin conta… |
| 2024-11-21 |
Class II
|
Ongoing |
Z-0783-2025 |
Medline custom medical procedure kits labeled as: 1) FREE FLAP BASIC SET-UP PK, REF DYNJ0991320J; 2) MVFF/FIBU #54-… |
— |
Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin conta… |
| 2024-11-21 |
Class II
|
Ongoing |
Z-0782-2025 |
See DocMan |
— |
Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin conta… |
| 2024-11-21 |
Class II
|
Ongoing |
Z-0781-2025 |
Medline custom medical procedure kits labeled as: 1) NASAL PACK, REF DYNJ67789A. |
— |
Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin conta… |
| 2024-11-21 |
Class II
|
Ongoing |
Z-0780-2025 |
Medline custom medical procedure kits labeled as: 1) UMC DR. BAKER SUPPLEMENT, REF DYNJ69476; 2) DIEP FLAP, REF DYN… |
— |
Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin conta… |
| 2024-11-21 |
Class II
|
Ongoing |
Z-0779-2025 |
Medline custom medical procedure kits labeled as: 1) VP SHUNT CDS, REF CDS983470D; 2) 1/2X1/2 NEURO SPONGE PACK-LF,… |
— |
Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin conta… |
| 2024-11-21 |
Class II
|
Ongoing |
Z-0778-2025 |
Medline custom medical procedure kits labeled as: 1) OPEN HEART CDS-LF, REFCDS840451M; 2) NEURO PACK, REFDYNJ41516M… |
— |
Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin conta… |
| 2024-11-21 |
Class II
|
Ongoing |
Z-0777-2025 |
Medline custom medical procedure kits labeled as: 1) CATH LAB PACK-LF, REF DYNJ0382559M; 2) CRANI, REF DYNJ56001B; … |
— |
Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin conta… |
| 2024-11-18 |
Class II
|
Ongoing |
Z-1042-2025 |
Medline procedure kits labeled as: 1) CENTRAL LINE DRESSING KIT, Reorder number DYNDC3189; dressing change tray |
— |
Certain Medline kits were manufactured and distributed with Procedure Masks with SO SOFT Earloops, and SOFT TOUCH II Surgical Masks which were subsequently reca… |
| 2024-11-18 |
Class II
|
Ongoing |
Z-1041-2025 |
Medline procedure kits labeled as: 1) SHORT TERM INFUSAPORT ACCESS KIT, Reorder number DYNDC3188; surgery tray |
— |
Certain Medline kits were manufactured and distributed with Procedure Masks with SO SOFT Earloops, and SOFT TOUCH II Surgical Masks which were subsequently reca… |
| 2024-11-18 |
Class II
|
Ongoing |
Z-1040-2025 |
Medline procedure kits labeled as: 1) Port Access Kit, Reorder number CVI5130; 2) VANTEX 7FR 3L 20CM CVC STOCK+ BUN… |
— |
Certain Medline kits were manufactured and distributed with Procedure Masks with SO SOFT Earloops, and SOFT TOUCH II Surgical Masks which were subsequently reca… |
| 2024-11-18 |
Class II
|
Ongoing |
Z-0698-2025 |
HUDSON RCI mBrace, ET Tube Holder with Bite Block and 4 Point Head Strap, REF DYNJMBRC4B; tracheal tube fixation device |
— |
Complaint defects have been noted regarding the adhesive elements of the device and the frame of the holder putting additional pressure on the patient's cheekbo… |
| 2024-11-18 |
Class II
|
Ongoing |
Z-0697-2025 |
HUDSON RCI mBrace, ET Tube Holder with 4 Point Head Strap, REF DYNJMBRC4; tracheal tube fixation device |
— |
Complaint defects have been noted regarding the adhesive elements of the device and the frame of the holder putting additional pressure on the patient's cheekbo… |
| 2024-11-18 |
Class II
|
Ongoing |
Z-0696-2025 |
HUDSON RCI mBrace, ET Tube Holder with Bite Block and 2 Point Head Strap, REF DYNJMBRC2B; tracheal tube fixation device |
— |
Complaint defects have been noted regarding the adhesive elements of the device and the frame of the holder putting additional pressure on the patient's cheekbo… |
| 2024-11-18 |
Class II
|
Ongoing |
Z-0695-2025 |
HUDSON RCI mBrace, ET Tube Holder and 2 Point Head Strap, REF DYNJMBRC2; tracheal tube fixation device |
— |
Complaint defects have been noted regarding the adhesive elements of the device and the frame of the holder putting additional pressure on the patient's cheekbo… |
| 2024-11-12 |
Class II
|
Ongoing |
Z-0760-2025 |
RUMMELL, Medline Item No. ST006ST |
— |
Weak seals may result in a breach of sterility, which may not be detectable to the user. This can lead to increased risk of contamination and infection. |
| 2024-11-12 |
Class II
|
Ongoing |
Z-0759-2025 |
ST IUD REMOVAL HOOK 10" (504090), Medline Item No. I68785 |
— |
Weak seals may result in a breach of sterility, which may not be detectable to the user. This can lead to increased risk of contamination and infection. |
| 2024-11-12 |
Class II
|
Ongoing |
Z-0758-2025 |
ST REPROCESSED BRUNS CURETTE #00 (BC00), Medline Item No. 67600K |
— |
Weak seals may result in a breach of sterility, which may not be detectable to the user. This can lead to increased risk of contamination and infection. |
| 2024-11-12 |
Class II
|
Ongoing |
Z-0757-2025 |
STERILE MAGILL FORCEP (MAGF9), Medline Item No. 66790 |
— |
Weak seals may result in a breach of sterility, which may not be detectable to the user. This can lead to increased risk of contamination and infection. |
| 2024-11-12 |
Class II
|
Ongoing |
Z-0756-2025 |
ST OR MAYO HEGAR NEEDLEHOLDER 6"(OR2500), Medline Item No. 67870 |
— |
Weak seals may result in a breach of sterility, which may not be detectable to the user. This can lead to increased risk of contamination and infection. |
| 2024-11-12 |
Class II
|
Ongoing |
Z-0755-2025 |
O.R. SCISSORS, S/B, 5.5 STERILE, Medline Item No. DYND04000 |
— |
Weak seals may result in a breach of sterility, which may not be detectable to the user. This can lead to increased risk of contamination and infection. |
| 2024-11-12 |
Class II
|
Ongoing |
Z-0754-2025 |
STERILE STRT KELLY HEMOSTAT (SK8039S), Medline Item No. 66695 |
— |
Weak seals may result in a breach of sterility, which may not be detectable to the user. This can lead to increased risk of contamination and infection. |
| 2024-11-06 |
Class II
|
Ongoing |
Z-0726-2025 |
Medline brand, medical procedure convenience kits, labeled as: 1) LAMINECTOMY CDS-LF, SKU CDS780045N; 2) NEURO CRANIOT… |
— |
Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw mat… |
| 2024-11-06 |
Class II
|
Ongoing |
Z-0725-2025 |
KIT,SPINE LH Convenience kit, SKU DYNJ906448A. |
— |
Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw mat… |
| 2024-11-06 |
Class II
|
Ongoing |
Z-0724-2025 |
Medline brand, medical procedure convenience kits, labeled as: 1) NEURO CRANIOTOMY CDS #36-RF, SKU CDS780119T; 2) NEUR… |
— |
Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw mat… |
| 2024-11-06 |
Class II
|
Ongoing |
Z-0723-2025 |
Medline brand, medical procedure convenience kits, labeled as: 1) CRANIOTOMY, SKU CDS982719X; 2) MVFF/FIBU #54-RF, SKU D… |
— |
Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw mat… |
| 2024-11-06 |
Class II
|
Ongoing |
Z-0722-2025 |
SEPTOPLASTY PACK Convenient kit, SKU DYNJ44759F. Convenience kits used for various procedures. |
— |
Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw mat… |
| 2024-11-06 |
Class II
|
Ongoing |
Z-0721-2025 |
Medline brand, medical procedure convenience kits, labeled as: 1) MVFF/FIBU #54-RF , SKU DYNJ21927R; 2) DIEP FLAP, SKU … |
— |
Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw mat… |
| 2024-11-06 |
Class II
|
Ongoing |
Z-0720-2025 |
Medline brand, medical procedure convenience kits, labeled as: 1) SINUS CDS-1, SKU CDS982901F; 2) NASAL PACK, SKU DYNJ17… |
— |
Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw mat… |
| 2024-11-06 |
Class II
|
Ongoing |
Z-0719-2025 |
DIEP FLAP Convenience kit, SKU DYNJ910120. Convenience kits used for various procedures. |
— |
Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw mat… |
| 2024-11-06 |
Class II
|
Ongoing |
Z-0718-2025 |
FESS-MB PACK-LF Convenience kit, SKU DYNJ0888159I. Convenience kits used for various procedures.. |
— |
Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw mat… |
| 2024-11-06 |
Class II
|
Ongoing |
Z-0717-2025 |
MAJOR NEURO PACK-LF Convenience kit, SKU DYNJ0578916X. Convenience kits used for various procedures. |
— |
Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw mat… |
| 2024-10-25 |
Class II
|
Ongoing |
Z-0558-2025 |
ENDO KIT, Medline Kit SKU DYKE1577A, Component Number 57469, 10 per case; Medline Convenience Kits containing Single Us… |
— |
Identified lots of Olympus product may be missing sterile and manufacturing lot numbers and expiration dates on the sterile packaging. The information can be fo… |
| 2024-10-23 |
Class II
|
Ongoing |
Z-0361-2025 |
URINE KIT W/BD CUP, SKU DYLAB1001A; Component No. 503581 |
— |
Specimen container included in kits is labeled as sterile, but has been identified to be non-sterile. Long-term consequences may include unnecessary treatment a… |
| 2024-10-23 |
Class II
|
Ongoing |
Z-0360-2025 |
URINE KIT, SKU DYKM1845; Component No. 503581 |
— |
Specimen container included in kits is labeled as sterile, but has been identified to be non-sterile. Long-term consequences may include unnecessary treatment a… |
| 2024-10-23 |
Class II
|
Ongoing |
Z-0359-2025 |
URINE COLLECTION VHC, SKU DYLAB1016; Component No. 503581 |
— |
Specimen container included in kits is labeled as sterile, but has been identified to be non-sterile. Long-term consequences may include unnecessary treatment a… |
| 2024-10-23 |
Class II
|
Ongoing |
Z-0358-2025 |
URINE COLLECTION KIT, SKU DYKM1848A DYKM2005 DYKM2151 DYLAB1004 DYLAB1004A DYLAB1006 DYLAB1012 ; Component No. 50… |
— |
Specimen container included in kits is labeled as sterile, but has been identified to be non-sterile. Long-term consequences may include unnecessary treatment a… |
| 2024-10-23 |
Class II
|
Ongoing |
Z-0357-2025 |
URINALYSIS KIT 4, SKU DYLAB1021; Component No. 503581 |
— |
Specimen container included in kits is labeled as sterile, but has been identified to be non-sterile. Long-term consequences may include unnecessary treatment a… |
| 2024-10-23 |
Class II
|
Ongoing |
Z-0356-2025 |
UA KIT, SKU DYKM1690A; Component No. 503581 |
— |
Specimen container included in kits is labeled as sterile, but has been identified to be non-sterile. Long-term consequences may include unnecessary treatment a… |
| 2024-10-23 |
Class II
|
Ongoing |
Z-0355-2025 |
Lab Kit, SKU DYLAB1018; Component No. 503581 |
— |
Specimen container included in kits is labeled as sterile, but has been identified to be non-sterile. Long-term consequences may include unnecessary treatment a… |
| 2024-10-23 |
Class II
|
Ongoing |
Z-0354-2025 |
Clean Catch Kit, SKU DYKM1833A; Component No. 503581 |
— |
Specimen container included in kits is labeled as sterile, but has been identified to be non-sterile. Long-term consequences may include unnecessary treatment a… |
| 2024-10-21 |
Class II
|
Ongoing |
Z-0465-2025 |
Medline Iris Scissors, Single-Use, Curved, Standard 4.5 , Model Nos. DYNJ04049 (cases), DYNJ04049H (eaches) |
— |
Tip protector may fall off within the packaging, resulting in compromised sterile barrier system and loss of sterility. |
| 2024-10-16 |
Class II
|
Ongoing |
Z-0515-2025 |
MEDLINE procedure kits labeled as follows: 1) L&D CONTINUOUS EPIDURAL TRAY, REF PAIN1699; 2) L&D CONTINUOUS EPIDURAL … |
— |
The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position. |
| 2024-10-16 |
Class II
|
Ongoing |
Z-0514-2025 |
MEDLINE procedure kits labeled as follows: 1) NEURAXIAL KIT, REF PAIN1876A |
— |
The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position. |
| 2024-10-16 |
Class II
|
Ongoing |
Z-0513-2025 |
MEDLINE procedure kits labeled as follows: 1) CONT EPI 20G W/HUSTEAD, REF PAIN1069B; 2) CSE TRAY, REF PAIN1941; 3) T… |
— |
The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position. |
| 2024-10-16 |
Class II
|
Ongoing |
Z-0512-2025 |
MEDLINE procedure kits labeled as follows: 1) PERIPHERAL CONTINUOUS NERVE BL, REF PAIN1423A; 2) CONT. 20G EPI MRI COM… |
— |
The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position. |
| 2024-10-16 |
Class II
|
Ongoing |
Z-0511-2025 |
MEDLINE procedure kits labeled as follows: 1) ECHOSTIM BLOCK SET, REF DYNJRA9043S; 2) ULTRASOUND BLOCK PREP TRAY, REF… |
— |
The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position. |
| 2024-10-16 |
Class II
|
Ongoing |
Z-0510-2025 |
MEDLINE procedure kits labeled as follows: 1) 20G EPI CATH SINGLE STERILE, REF EPICATH19 2) 20G EPI CATH SINGLE STER… |
— |
The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position. |
| 2024-10-16 |
Class II
|
Ongoing |
Z-0509-2025 |
MEDLINE procedure kits labeled as follows: 1) COMBINED SPINAL AND EPIDURAL, REF DYNJRA1268B; 2) COMBINED SPINAL AND… |
— |
The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position. |
| 2024-10-16 |
Class II
|
Ongoing |
Z-0508-2025 |
MEDLINE NEXUS 19/20G CATH CONNECTOR, Medline SKU REF NEXCONNECT, Catheter Connector |
— |
The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position. |
| 2024-10-15 |
Class II
|
Ongoing |
Z-0534-2025 |
Medline Shoulder Repair Pack-LF, REF DYNJ82607, 2 kits/case, sterile. |
— |
Some of the suture packages within the convenience kits contain the incorrect needle type/size and suture diameter/length. |
| 2024-10-15 |
Class II
|
Ongoing |
Z-0533-2025 |
(1) Medline Pacer Implant Pack, REF DYNJ59194A, 4 kits/case, sterile; and (2) Medline Thoracotomy Morristown, REF DYNJ9… |
— |
Some of the suture packages within the convenience kits contain the incorrect needle type/size and suture diameter/length. |
| 2024-10-15 |
Class II
|
Ongoing |
Z-0532-2025 |
(1) Medline Open Heart CDS, REF CDS840132O, packaged 1 kit/case, non-sterile; and (2) Medline Dr. Davies CV, REF DYNJ90… |
— |
Some of the suture packages within the convenience kits contain the incorrect needle type/size and suture diameter/length. |
| 2024-10-09 |
Class II
|
Ongoing |
Z-0649-2025 |
MEDLINE convenience kits labeled as: 1) ORTHO LAMINECTOMY-LF, REF CDS780112J; 2) NEURO CRANIOTOMY CDS #36-RF, REF CDS… |
— |
Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker. |
| 2024-10-09 |
Class II
|
Ongoing |
Z-0648-2025 |
MEDLINE convenience kits labeled as: 1) MINOR EYE TRAY #81, REF DYNJ27466S; 2) EYE PACK, REF DYNJ41207C; 3) CATAR… |
— |
Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker. |
| 2024-10-09 |
Class II
|
Ongoing |
Z-0647-2025 |
MEDLINE convenience kits labeled as: 1) TOT/ GYN LITHOTOMY CDS, REF CDS985431J; 2) TOT/ GYN LITHOTOMY CDS, REF CDS9… |
— |
Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker. |
| 2024-10-09 |
Class II
|
Ongoing |
Z-0646-2025 |
MEDLINE convenience kits labeled as: 1) MAJOR LITHOTOMY CDS-LF, REF CDS760056G; 2) LAVH CDS, REF CDS983411J; 3) M… |
— |
Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker. |
| 2024-10-09 |
Class II
|
Ongoing |
Z-0645-2025 |
MEDLINE convenience kits labeled as: 1) C-SECTION OR 30 CDS, REF CDS820075V; 2) C-SECTION OR 30 CDS, REF CDS820075W; … |
— |
Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker. |
| 2024-10-09 |
Class II
|
Ongoing |
Z-0644-2025 |
MEDLINE convenience kits labeled as: 1) CIRCUMCISION PACK, REF DYNJ16826O; 2) D-CIRCUMCISION PACK, REF DYNJ64432; … |
— |
Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker. |
| 2024-10-09 |
Class II
|
Ongoing |
Z-0643-2025 |
MEDLINE convenience kits labeled as: 1) GYN LAPAROSCOPY-LF, REF CDS760059I; 2) GYN LAPAROSCOPY CDS #34-RF, REF CDS9… |
— |
Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker. |
| 2024-10-09 |
Class II
|
Ongoing |
Z-0642-2025 |
MEDLINE convenience kits labeled as: 1) LITHOTOMY/PELVISCOPY PACK, REF DYNJ0531985R; 2) PELVISCOPY PACK-LF, REF DYN… |
— |
Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker. |
| 2024-10-09 |
Class II
|
Ongoing |
Z-0641-2025 |
MEDLINE convenience kits labeled as: 1) VAGINAL, REF CDS984955M; 2) DAY SURG LARGE VAG CDS, REF CDS984995M; 3) MA… |
— |
Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker. |
| 2024-10-09 |
Class II
|
Ongoing |
Z-0640-2025 |
MEDLINE convenience kits labeled as: 1) BASIC NEURO PACK, REF CDS780202P; 2) BASIC NEURO PACK, REF CDS780202Q; 3)… |
— |
Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker. |
| 2024-10-09 |
Class II
|
Ongoing |
Z-0639-2025 |
MEDLINE convenience kits labeled as: L&D MINOR PACK, REF DYNJ82672 |
— |
Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker. |
| 2024-10-09 |
Class II
|
Ongoing |
Z-0638-2025 |
MEDLINE convenience kits labeled as: 1) CLEAN CLOSING PACK, REF DYNJ80686A; 2) CLEAN CLOSURE PACK GREEN, REF DYNJ84… |
— |
Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker. |
| 2024-10-09 |
Class II
|
Ongoing |
Z-0637-2025 |
MEDLINE convenience kits labeled as: 1) BURN, REF CDS983465M; 2) BURN, REF CDS983465N; 3) BURN PACK, REF DYNJ63331… |
— |
Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker. |
| 2024-10-09 |
Class II
|
Ongoing |
Z-0636-2025 |
MEDLINE convenience kits labeled as: COLON WOUND CLOSURE PACK, REF DYNJ52141B |
— |
Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker. |
| 2024-10-09 |
Class II
|
Ongoing |
Z-0635-2025 |
Refer to RES or lead review memo for complete list of affected reference/catalog numbers |
— |
Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker. |
| 2024-10-09 |
Class II
|
Ongoing |
Z-0634-2025 |
MEDLINE convenience kits labeled as: 1) LAKELAND SINGLE BASIN PACK-LF, REF DYNJ0619907I; 2) LAKELAND SINGLE BASIN P… |
— |
Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker. |
| 2024-10-09 |
Class II
|
Ongoing |
Z-0633-2025 |
MEDLINE convenience kits labeled as: 1) MAMMOPLASTY-LF, REF CDS983478L; 2) MAMMOPLASTY-LF, REF CDS983478M; 3) PLASTI… |
— |
Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker. |
| 2024-10-09 |
Class II
|
Ongoing |
Z-0632-2025 |
MEDLINE convenience kits labeled as: PORT INSERTION PACK, REF DYNJ81597 |
— |
Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker. |
| 2024-10-09 |
Class II
|
Ongoing |
Z-0631-2025 |
MEDLINE convenience kits labeled as: 1) GENERAL ENDOSCOPY PACK, REF DYNJ44673G; 2) ENDO BLADDER PACK, REF DYNJ49672… |
— |
Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker. |
| 2024-10-09 |
Class II
|
Ongoing |
Z-0630-2025 |
MEDLINE convenience kits labeled as: 2) ABDOMINAL LAPAROSCOPY, REF CDS760057K; 3) ABDOMINAL LAPAROSCOPY, REF CDS76005… |
— |
Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker. |
| 2024-10-09 |
Class II
|
Ongoing |
Z-0629-2025 |
MEDLINE convenience kits labeled as: 1) ZALE HEAD & NECK CDS, REF CDS983184I; 2) ENT MINOR, REF CDS983466L; 3) EAR, … |
— |
Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker. |
| 2024-10-09 |
Class II
|
Ongoing |
Z-0628-2025 |
MEDLINE convenience kits labeled as: 1) ORAL SURGERY PK RFID, REF DYNJ52404I; 2) ORL PACK, REF DYNJ59073B; 3) OR… |
— |
Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker. |
| 2024-10-09 |
Class II
|
Ongoing |
Z-0627-2025 |
MEDLINE convenience kits labeled as: 1) BREAST BIOPSY PACK-LF, REF DYNJ0160598C; 2) BREAST BIOPSY PACK-LF, REF DYN… |
— |
Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker. |
| 2024-10-09 |
Class II
|
Ongoing |
Z-0626-2025 |
MEDLINE convenience kits labeled as: 1) CVL PACK, REF DYNJ00281O; 2) VASCULAR ACCESS PACK-LF, REF DYNJ0101291F; 3… |
— |
Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker. |
| 2024-10-09 |
Class II
|
Ongoing |
Z-0625-2025 |
MEDLINE convenience kits labeled as: 1) MAJOR VASCULAR-LF, REF CDS840232L; 2) AVF-LF, REF CDS840233I; 3) GENERAL AAA… |
— |
Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker. |
| 2024-10-09 |
Class II
|
Ongoing |
Z-0624-2025 |
MEDLINE convenience kits labeled as: 1) ANGIO PACK #2, REFDYNJ39185D; 2) CV MINOR CATH LAB PACK, REFDYNJ44997J; 3… |
— |
Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker. |
| 2024-10-09 |
Class II
|
Ongoing |
Z-0623-2025 |
MEDLINE medical convenience kits labeled as: 1) ACETABULAR PACK-LF, REF DYNJ0572894I; 2) LOCAL BASIC, REF DYNJ34418… |
— |
Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker. |
| 2024-10-09 |
Class II
|
Ongoing |
Z-0622-2025 |
MEDLINE convenience kits labeled as: 1) TRACH TOTE, REF DYNJ85691; 2) TRACHEOSTOMY, REF DYNJ902123J |
— |
Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker. |
| 2024-10-04 |
Class II
|
Ongoing |
Z-0350-2025 |
ARTHROSCOPY Convenience kit used for surgical procedures, SKU SYNJ910004C |
— |
Products within a Medline pack may be impacted by a packaging error in which an incomplete seal has formed on the packaging thereby creating a packaging seal ga… |
| 2024-10-04 |
Class II
|
Ongoing |
Z-0349-2025 |
CARROLLTON HIP FX Convenience kit used for surgical procedures, SKU SYNJ910003A |
— |
Products within a Medline pack may be impacted by a packaging error in which an incomplete seal has formed on the packaging thereby creating a packaging seal ga… |
| 2024-09-04 |
Class II
|
Ongoing |
Z-0180-2025 |
Medline EYE PACK, REF LYN036EPESB; medical procedure convenience kit |
— |
It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product… |
| 2024-09-04 |
Class II
|
Ongoing |
Z-0179-2025 |
Medline brand medical procedure convenience kits, labeled as: 1) NEW LONDON TOTAL KNEE CDS, REF CDS982519W; 2) HAND… |
— |
It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product… |
| 2024-09-04 |
Class II
|
Ongoing |
Z-0178-2025 |
Medline brand medical procedure convenience kits, labeled as: 1) EYE PACK, REF DYNJ19492L; 2) PHACO PACK, REF DYNJ223… |
— |
It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product… |
| 2024-09-04 |
Class II
|
Ongoing |
Z-0177-2025 |
Medline brand medical procedure convenience kits, labeled as: a) OB PACK-LF, REF DYNJ0912449M; b) OB PACK, REF DYNJ… |
— |
It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product… |
| 2024-09-04 |
Class II
|
Ongoing |
Z-0176-2025 |
Medline brand medical procedure convenience kits, labeled as: a) ABDOMINAL HYSTERECTOMY TEGH-LF, REF DYNJ46730; b) … |
— |
It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product… |
| 2024-09-04 |
Class II
|
Ongoing |
Z-0175-2025 |
Medline brand medical procedure convenience kits, labeled as: a) LITHOTOMY PACK, REF DYNJ24362C; b) MAJOR GYNE LAPA… |
— |
It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product… |
| 2024-09-04 |
Class II
|
Ongoing |
Z-0174-2025 |
Medline brand medical procedure convenience kits, labeled as: 1) L&D/OB PACK-LF, REF DYNJ0213264O; 2) VAG DELIVERY HL… |
— |
It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product… |
| 2024-09-04 |
Class II
|
Ongoing |
Z-0173-2025 |
Medline brand medical procedure convenience kits, labeled as: a) NEURO PACK, REF DYNJ37909A; b) SHUNT PACK, REF DYN… |
— |
It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product… |
| 2024-09-04 |
Class II
|
Ongoing |
Z-0172-2025 |
Medline AMBULATORY MINI PACK, REF DYNJ82579; medical procedure convenience kit |
— |
It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product… |
| 2024-09-04 |
Class II
|
Ongoing |
Z-0171-2025 |
Medline brand medical procedure convenience kits, labeled as: a) UNIVERSAL DRAPE PACK, REF DYNJ44114; b) DRAPE PACK… |
— |
It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product… |
| 2024-09-04 |
Class II
|
Ongoing |
Z-0170-2025 |
Medline TUBAL LIGATION PACK, REF DYNJ66230B; medical procedure convenience kit |
— |
It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product… |
| 2024-09-04 |
Class II
|
Ongoing |
Z-0169-2025 |
Medline PEDIATRIC DRAPE PK, REF DYNJ81297; medical procedure convenience kit |
— |
It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product… |
| 2024-09-04 |
Class II
|
Ongoing |
Z-0168-2025 |
Medline IV TEAM PICC, REF DYNJ48222; medical procedure convenience kit |
— |
It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product… |
| 2024-09-04 |
Class II
|
Ongoing |
Z-0167-2025 |
Medline CHEST TUBE INSERTION TRAY ADUL, REF CHT1165; medical procedure convenience kit |
— |
It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product… |
| 2024-09-04 |
Class II
|
Ongoing |
Z-0166-2025 |
Medline brand medical procedure convenience kits, labeled as: 1) THORACENTESIS TRAY, REF 00-400616J; 2) HH PACK SONICAT… |
— |
XXX |
| 2024-09-04 |
Class II
|
Ongoing |
Z-0165-2025 |
Medline brand medical procedure convenience kits, labeled as: a) PLASTIC PACK, REF DYNJ42735A; b) DR SELEM PACK, RE… |
— |
It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product… |
| 2024-09-04 |
Class II
|
Ongoing |
Z-0164-2025 |
Medline brand medical procedure convenience kits, labeled as: a) TRAY ADD A CATH FOL UM MF 10ML, REF DYND150200S; b… |
— |
It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product… |
| 2024-09-04 |
Class II
|
Ongoing |
Z-0163-2025 |
Medline DIALYSIS PACK, REF DYNJ36932A; medical procedure convenience kit |
— |
It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product… |
| 2024-09-04 |
Class II
|
Ongoing |
Z-0162-2025 |
Medline CENTRAL CATHETER INSERTION TRA, REF CVI680C; medical procedure convenience kit |
— |
It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product… |
| 2024-09-04 |
Class II
|
Ongoing |
Z-0161-2025 |
Medline brand medical procedure convenience kits, labeled as: 1) CYSTO CDS, REF CDS983525D; 2) CYSTO CDS, REF CDS98… |
— |
It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product… |
| 2024-09-04 |
Class II
|
Ongoing |
Z-0160-2025 |
Medline brand medical procedure convenience kits, labeled as: 1) T&A CDS-LF, REF CDS982091I; 2) TONSIL CDS, REF CDS… |
— |
It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product… |
| 2024-09-04 |
Class II
|
Ongoing |
Z-0159-2025 |
Medline DENTAL PACK, REF DYNJ64086B; medical procedure convenience kit |
— |
It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product… |
| 2024-09-04 |
Class II
|
Ongoing |
Z-0158-2025 |
Medline brand medical procedure convenience kits, labeled as: a) CONE BIOPSY PACK, REF DYNJ17534L; b) BIOPSY TRAY, … |
— |
It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product… |
| 2024-09-04 |
Class II
|
Ongoing |
Z-0157-2025 |
Medline brand medical procedure convenience kits, labeled as: a) KIT LINE INSERTION, REF CVI4730A; b) KIT LINE INSE… |
— |
It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product… |
| 2024-09-04 |
Class II
|
Ongoing |
Z-0156-2025 |
Medline brand, medical procedure convenience kits, labeled as: a) CUH OPEN HEART A B C - CDS, REF CDS983202I; a) PI… |
— |
It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product… |
| 2024-09-04 |
Class II
|
Ongoing |
Z-0155-2025 |
Medline brand, medical procedure convenience kits, labeled as: a) RADIOLOGY LP TRAY, REF DYNDH1609; b) CARDIAC CATH… |
— |
It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product… |
| 2024-09-04 |
Class II
|
Ongoing |
Z-0154-2025 |
Medline brand, medical procedure convenience kits, labeled as: a) SET UP PACK, REF DYNJ36320A; b) ANGIOGRAM WRO-LF, R… |
— |
It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product… |
| 2024-09-04 |
Class II
|
Ongoing |
Z-0153-2025 |
Medline brand medical procedure convenience kit, labeled as: a) PAIN PROCEDURE PACK, REF DYNJ80370A; b) DR HEFZY BLOCK … |
— |
It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product… |
| 2024-09-04 |
Class II
|
Ongoing |
Z-0152-2025 |
Medline CV ANESTHESIA - ROOM SET UP, REF DYNJ905503F; medical procedure convenience kit |
— |
It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product… |
| 2024-09-04 |
Class II
|
Ongoing |
Z-0151-2025 |
Centurion OB TRAY, REF MNS13965A; medical procedure convenience kit |
— |
It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product… |
| 2024-09-04 |
Class II
|
Ongoing |
Z-0150-2025 |
Centurion brand, medical procedure convenience kits, labeled as: a) FLOOR - UMBILICAL CUT DOWN TRA, b) PLASTICS SUTUR… |
— |
It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product… |
| 2024-09-04 |
Class II
|
Ongoing |
Z-0149-2025 |
Centurion EP LAB INSTRUMENT KIT, REF MNS10480; medical procedure convenience kit |
— |
It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product… |
| 2024-09-04 |
Class II
|
Ongoing |
Z-0148-2025 |
Centurion PEDIATRIC/ADULT TRACHEOSTOMY T, REF TC7895; medical procedure convenience kit |
— |
It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product… |
| 2024-09-03 |
Class II
|
Ongoing |
Z-0133-2025 |
(1) Centurion Sterile CirClamp, Reorder #200CR; (2) Centurion CirClamp with 1.1cm Bell and Insert, Reorder #210CR, Ster… |
— |
Product has been identified as having holes in the packaging. |
| 2024-08-30 |
Class II
|
Ongoing |
Z-0034-2025 |
MEDLINE Automatic Digital Blood Pressure Monitor, REF MDS1001UT. |
— |
It has been determined that certain Blood Pressure Monitors containing a faulty microchip have failed to power on or have shown display screen issues after the … |
| 2024-08-30 |
Class II
|
Ongoing |
Z-0033-2025 |
MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001U. |
— |
It has been determined that certain Blood Pressure Monitors containing a faulty microchip have failed to power on or have shown display screen issues after the … |
| 2024-08-30 |
Class II
|
Ongoing |
Z-0032-2025 |
MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001 |
— |
It has been determined that certain Blood Pressure Monitors containing a faulty microchip have failed to power on or have shown display screen issues after the … |
| 2024-08-28 |
Class II
|
Ongoing |
Z-0124-2025 |
MEDLINE OPEN HEART NIMC KIT, REF DYNJ908840 |
— |
Medline Industries, LP. has identified certain kits containing the recalled Medtronic lots of the DLP Vessel Cannulae. During manufacturing of the three listed … |
| 2024-08-28 |
Class II
|
Ongoing |
Z-0123-2025 |
MEDLINE KIT CV I II, REF DYNJ906071B |
— |
Medline Industries, LP. has identified certain kits containing the recalled Medtronic lots of the DLP Vessel Cannulae. During manufacturing of the three listed … |
| 2024-08-28 |
Class II
|
Ongoing |
Z-0122-2025 |
MEDLINE OPEN HEART, REF DYNJ904261B |
— |
Medline Industries, LP. has identified certain kits containing the recalled Medtronic lots of the DLP Vessel Cannulae. During manufacturing of the three listed … |
| 2024-08-28 |
Class II
|
Ongoing |
Z-0121-2025 |
MEDLINE OPEN HEART PACK, REF DYNJ66216C |
— |
Medline Industries, LP. has identified certain kits containing the recalled Medtronic lots of the DLP Vessel Cannulae. During manufacturing of the three listed … |
| 2024-08-28 |
Class II
|
Ongoing |
Z-0120-2025 |
MEDLINE HEART OVERHEAD TABLE PACK, REF DYNJ0778508J |
— |
Medline Industries, LP. has identified certain kits containing the recalled Medtronic lots of the DLP Vessel Cannulae. During manufacturing of the three listed … |
| 2024-08-28 |
Class II
|
Ongoing |
Z-0119-2025 |
MEDLINE HEART CABG CDS, REF CDS983376R |
— |
Medline Industries, LP. has identified certain kits containing the recalled Medtronic lots of the DLP Vessel Cannulae. During manufacturing of the three listed … |
| 2024-08-28 |
Class II
|
Ongoing |
Z-0053-2025 |
Medline Sterile Laparoscopy Pack, DYNJ68187A (REF), containing the component ConMed/Unimax Detachable Endo Pocket |
— |
CONMED Corporation (vendor) initiated a recall for select lot numbers of the Unimax Detachable Endo Pocket. The Detachable Endo Pocket is indicated for use as … |
| 2024-06-27 |
Class II
|
Ongoing |
Z-3121-2024 |
Medline convenience kits containing semi-rigid suction liners labeled as follows: a) LAMINECTOMY CDS, Pack Number CDS98… |
— |
Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and lots of 1500 cc semi-rigid liners manufactured from 09/2023-11/… |
| 2024-06-27 |
Class II
|
Ongoing |
Z-3120-2024 |
Medline convenience kits containing semi-rigid suction liners labeled as follows: a) AMB VITRECTOMY, Pack Number DYNJ… |
— |
XXX |
| 2024-06-27 |
Class II
|
Ongoing |
Z-3119-2024 |
Medline convenience kits containing semi-rigid suction liners labeled as follows: MERCY TIFFIN C-SECTION, Pack Number D… |
— |
Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and lots of 1500 cc semi-rigid liners manufactured from 09/2023-11/… |
| 2024-06-27 |
Class II
|
Ongoing |
Z-3118-2024 |
Medline convenience kits containing semi-rigid suction liners labeled as follows: MTHZ GYN LAPAROSCOPY, Pack Number DYN… |
— |
Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and lots of 1500 cc semi-rigid liners manufactured from 09/2023-11/… |
| 2024-06-27 |
Class II
|
Ongoing |
Z-3117-2024 |
Medline convenience kits containing semi-rigid suction liners labeled as follows: KIT NEURO SHUNT ST LOUIS CHILD, Pack N… |
— |
Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and lots of 1500 cc semi-rigid liners manufactured from 09/2023-11/… |
| 2024-06-27 |
Class II
|
Ongoing |
Z-3116-2024 |
Medline convenience kits containing semi-rigid suction liners labeled as follows: ANES TURNOVER KIT-LF, Pack Number DYN… |
— |
Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and lots of 1500 cc semi-rigid liners manufactured from 09/2023-11/… |
| 2024-06-27 |
Class II
|
Ongoing |
Z-3115-2024 |
Medline convenience kits containing semi-rigid suction liners labeled as follows: NICU ADMIT KIT, Pack Number DYKA1014G |
— |
Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and lots of 1500 cc semi-rigid liners manufactured from 09/2023-11/… |
| 2024-06-27 |
Class II
|
Ongoing |
Z-3114-2024 |
Medline convenience kits containing semi-rigid suction liners labeled as follows: a) ENDO KIT, Pack Number DYKE1092B; … |
— |
Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and lots of 1500 cc semi-rigid liners manufactured from 09/2023-11/… |
| 2024-06-27 |
Class II
|
Ongoing |
Z-3113-2024 |
Medline convenience kits containing semi-rigid suction liners labeled as follows: a) MINOR BREAST, Pack Number DYNJ90… |
— |
Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and lots of 1500 cc semi-rigid liners manufactured from 09/2023-11/… |
| 2024-06-27 |
Class II
|
Ongoing |
Z-3112-2024 |
Medline convenience kits containing semi-rigid suction liners labeled as follows: a) ENDO KIT, Pack Number DYKE1350D; … |
— |
Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and lots of 1500 cc semi-rigid liners manufactured from 09/2023-11/… |
| 2024-06-27 |
Class II
|
Ongoing |
Z-3111-2024 |
Medline convenience kits containing semi-rigid suction liners labeled as follows: a) ENDO BRONCH PACK, Pack Number DYKE… |
— |
Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and lots of 1500 cc semi-rigid liners manufactured from 09/2023-11/… |
| 2024-06-27 |
Class II
|
Ongoing |
Z-3110-2024 |
Medline convenience kits containing semi-rigid suction liners labeled as follows: a) MINOR PROCEDURE, Pack Number CDS98… |
— |
Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and lots of 1500 cc semi-rigid liners manufactured from 09/2023-11/… |
| 2024-06-27 |
Class II
|
Ongoing |
Z-3109-2024 |
Medline convenience kits containing semi-rigid suction liners labeled as follows: a) BAPTIST FLOYD BRONCHOSCOPY, Pack N… |
— |
Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and lots of 1500 cc semi-rigid liners manufactured from 09/2023-11/… |
| 2024-06-27 |
Class II
|
Ongoing |
Z-3108-2024 |
Medline convenience kits containing semi-rigid suction liners labeled as follows: DENTAL, Pack Number DYNJ909451A |
— |
Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and lots of 1500 cc semi-rigid liners manufactured from 09/2023-11/… |
| 2024-06-27 |
Class II
|
Ongoing |
Z-3107-2024 |
Medline convenience kits containing semi-rigid suction liners labeled as follows: a) OPEN HEART KIT,ALTA BATES HOSP, … |
— |
Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and lots of 1500 cc semi-rigid liners manufactured from 09/2023-11/… |
| 2024-06-27 |
Class II
|
Ongoing |
Z-3106-2024 |
Medline convenience kits containing semi-rigid suction liners labeled as follows: a) ANESTHESIA CIRCUIT-LF, Pack Number… |
— |
Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and lots of 1500 cc semi-rigid liners manufactured from 09/2023-11/… |
| 2024-06-27 |
Class II
|
Ongoing |
Z-3105-2024 |
Medline Semi-rigid suction liners labeled as follows: a) SEMI RIGID SUCTION LINER, REF OR515; b) SEMI RIGID SUCTION L… |
— |
Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and lots of 1500 cc semi-rigid liners manufactured from 09/2023-11/… |
| 2024-06-18 |
Class II
|
Ongoing |
Z-3072-2024 |
ANESTHESIA TURNOVER KIT, Pack Number DYNJAA0377A |
— |
A non-sterile Mastisol component, which was not labeled as being sterile or non-sterile, was placed in the non-sterile portion of certain sterile convenience ki… |
| 2024-06-18 |
Class II
|
Ongoing |
Z-3071-2024 |
ANESTHESIA TURNOVER KIT, Pack Number DYNJAA0377 |
— |
A non-sterile Mastisol component, which was not labeled as being sterile or non-sterile, was placed in the non-sterile portion of certain sterile convenience ki… |
| 2024-06-18 |
Class II
|
Ongoing |
Z-3070-2024 |
KIT PEDI CRANI LAMI, Pack Number DYNJ907372A |
— |
A non-sterile Mastisol component, which was not labeled as being sterile or non-sterile, was placed in the non-sterile portion of certain sterile convenience ki… |
| 2024-06-18 |
Class II
|
Ongoing |
Z-3069-2024 |
CRANIOTOMY PACK, Pack Number DYNJ46552O |
— |
A non-sterile Mastisol component, which was not labeled as being sterile or non-sterile, was placed in the non-sterile portion of certain sterile convenience ki… |
| 2024-05-07 |
Class II
|
Ongoing |
Z-3095-2024 |
Medline ReNewal Reprocessed Ethicon Harmonic ACE+7 Shears w/ Adv. Hemostasis Use Only w/GEN11 SW v2018-1 and Lower 5mm x… |
— |
Potential for an incomplete seal on the packaging tray. |
| 2024-05-07 |
Class II
|
Ongoing |
Z-3094-2024 |
Medline ReNewal Reprocessed Covidien LigaSure Impact, Sealer/Divider, Nano-Coated, Compatible w/ FT10 18cm FT10 SW Versi… |
— |
Potential for an incomplete seal on the packaging tray. |
| 2024-05-07 |
Class II
|
Ongoing |
Z-3093-2024 |
Medline ReNewal Reprocessed Covidien LigaSure Maryland Jaw Sealer/Divider, Nano-Coated, Compatible w/ FT10 37 cm FT10 SW… |
— |
Potential for an incomplete seal on the packaging tray. |
| 2024-05-07 |
Class II
|
Ongoing |
Z-3092-2024 |
Medline ReNewal Reprocessed Covidien LigaSure Blunt Tip, Sealer/Divider, Nano-Coated, Compatible w/ FT10 37cm FT10 SW Ve… |
— |
Potential for an incomplete seal on the packaging tray. |
| 2024-04-30 |
Class II
|
Ongoing |
Z-2024-2024 |
MEDLINE STERILE IRIS SCISSORS CVD/STD REF DYNJ04049 (case) and DYNJ04049H (individual unit) |
— |
There is the potential of the tip protector to fall off 4.5" sterile, curved, Iris Scissors |
| 2024-04-22 |
Class II
|
Ongoing |
Z-1938-2024 |
MEDLINE LUER SLIP DISPOSABLE SYRINGE WITHOUT NEEDLE, REF SYR101020 |
— |
It has been identified that testing documentation does not support that the syringes can successfully deliver accurate volumes across the full range of their cl… |
| 2024-04-22 |
Class II
|
Ongoing |
Z-1937-2024 |
MEDLINE LUER LOCK DISPOSABLE SYRINGE WITHOUT NEEDLE, REF SYR101010 |
— |
It has been identified that testing documentation does not support that the syringes can successfully deliver accurate volumes across the full range of their cl… |
| 2024-04-17 |
Class II
|
Ongoing |
Z-1936-2024 |
Syringes labeled as: a) SYR 10ML L/L CONTROL, Item Numbers: 1. DNSC91881, 2. DYNJSYRPPC10; b) SYRINGE 20ML BLUE … |
— |
These syringes were identified to be affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and other quality issues have been identified t… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-3061-2024 |
Medline Convenience kits, labeled as: aa1) BURN PACK-LF, Pack Number DYNJ0781678S ; 2) BURN PACK , Pack Number DYN… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-3060-2024 |
Medline Convenience kits, labeled as: 1) KNEE ARTHROSCOPY CDS-LF , Pack Number CDS983874F ; 2) HAND, Pack Number C… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-3059-2024 |
Medline Convenience kits, labeled as: 1) BLOOD CULTURE COLLECTION KIT, Pack Number BP115; 2) NICU CNTRL LINE BLOOD… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-3058-2024 |
Medline Convenience kits, labeled as: BIOPSY TRAY-LF, Pack Number DYNDH1229 |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-3057-2024 |
Medline Convenience kits, labeled as: GAMMA NAIL CDS-LF , Pack Number CDS983505K |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-3056-2024 |
Medline Convenience kits, labeled as: 1) SUTURING SET PACK ASSY P791011, Pack Number 59112; 2) SUTURE SET, Pack Nu… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-3055-2024 |
Medline Convenience kits, containing Shenli syringes, labeled as: 1) LOCAL PACK, Pack Number DYNJ34129C ; 2) FTMC L… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-3054-2024 |
Medline Convenience kits labeled as: 1) ARTHROGRAPHY DRAPE PACK , Pack Number 00-399027M ; 2) ARTHROSCOPY CDS , Pack … |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-3053-2024 |
Medline Convenience kits labeled as: 1) C SCOPE DISPOSABLE KIT, Pack Code 613034700; 2) C SCOPE DISPOSABLE KIT, Pac… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-3052-2024 |
Medline Convenience kits labeled as: 1) SPECIAL PROCEDURE PACK ARTERI , Pack Number 00-399024X ; 2) ARTHROSCOPY TRAY,… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-3051-2024 |
Medline Convenience kits labeled as: 1) ADULT DRAWER 5, Pack Number ACC010647A ; 2) TUBAL LIGATION CDS, Pack Number C… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-3050-2024 |
Medline Convenience kits labeled as: 1) LABOR & DELIVERY CDS, Pack Number CDS830039AD; 2) FETAL SURGERY CDS-LF, Pack … |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-3049-2024 |
Medline Convenience kits labeled as: 1) OFFICE PACK FOR HYSTEROSCOPY, Pack Number C040100; 2) LAVH CDS, Pack Number C… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-3048-2024 |
Medline Convenience kits labeled as: 1) C-SECTION TRAY, Pack Number AM160B ; 2) C-SECTION TRAY, Pack Number AM160C ; … |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-3047-2024 |
Medline Convenience kits labeled as: 1) UROLOGY MINOR CDS , Pack Number CDS980371J ; 2) UROLOGY MINOR CDS , Pack Nu… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-3046-2024 |
Medline Convenience kits labeled as: 1) LAVH CDS, Pack Number CDS760049AB; 2) TUBAL LIGATION CDS, Pack Number CDS7600… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-3045-2024 |
Medline Convenience kits labeled as: 1) GROTH PELVISCOPY CDS, Pack Number CDS984187T ; 2) GROTH PELVISCOPY, Pack Nu… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-3044-2024 |
Medline Convenience kits labeled as: 1) PACK VAGINAL DELIVERY , Pack Number AM185B ; 2) LABOR & DELIVERY CDS, Pack Nu… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-3043-2024 |
Medline Convenience kits labeled as: HSG TRAY, Pack Number DYNDH1453 |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-3042-2024 |
Medline Convenience kits labeled as: 1) ANGIOGRAPHY DRAPE PACK, Pack Number 00-401327AA; 2) CORONARY ANGIO PACK-LF, P… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-3041-2024 |
Medline Convenience kits labeled as: 1) CHEST TUBE INSERTION TRAY, Pack Number DYNDA2063; 2) PULL D/C PACK, Pack Nu… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-3040-2024 |
Medline Convenience kits labeled as: 1) CHEST TUBE TRAY , Pack Number CHT2120; 2) CHEST TUBE INSERTION TRAY , Pack … |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-3039-2024 |
Medline Convenience kits labeled as: 1) OR CLEAN UP KIT, Pack Number DYK1002355X3, 2) CLEANING & CUTTING, Pack Numb… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-3038-2024 |
Medline Convenience kits labeled as: 1) ADMIT KIT , Pack Number DYKA1225B; 2) BRANSON SUPPLEMENTAL PACK , Pack Numb… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-3037-2024 |
Medline Convenience kits labeled as: 1) EP DRAPE PACK-LF, Pack Number DYNJ0209716K ; 2) MERCY COMBINED PACK-LF, Pac… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-3036-2024 |
Medline Convenience kits labeled as: 1) SH STRL UMBILICAL ACC PACK-LF, Pack Number DYNJ0621408V; 2) SH STRL UMBILIC… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-3035-2024 |
Medline Convenience kits labeled as: ADMIT KIT PILLOW BOX, Pack Number DYKA1389 |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-3034-2024 |
Medline Convenience kits labeled as: 1) KIT, MIDSTREAM, W/BZK/FUNNL,3O, Pack Number DYND30212; 2) PROCESSING KIT 3 … |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-3033-2024 |
Medline Convenience kits labeled as: 1) SYRINGE CNTRL 10ML RED L/L LP , Pack Number DYNJSYCPP10R ; 2) SYRINGE CNTRL… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-3032-2024 |
Medline Convenience kits labeled as: 1) SYR CONTROL PAD 12ML L/L, Pack Number DYNJSYR12CP; 2) MSC - AHMC ANAHEIM RE… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-3031-2024 |
Medline Convenience kits labeled as: 1) FILTER-.8 MICRON, Pack Number 2008; 2) ANES CIRCUIT 90IN EXP-LF, Pack Numbe… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-3030-2024 |
Medline Convenience kits labeled as: 1) STEREOTACTIC BREAST BIOPSY TRA, Pack Number BT1095 ; 2) BREAST BIOPSY TRAY,… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-3029-2024 |
Medline Convenience kits labeled as: 1) INFECTION DRIVELINE MANAGEMENT KIT, Pack Number DM645; 2) PICU LINE TRAY, P… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-3028-2024 |
Medline Convenience kits labeled as: 1) KIT GENERAL CLOSURE , Pack Number DYKMBNDL200A ; 2) KIT GENERAL CLOSURE , P… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-3027-2024 |
Medline Convenience kits labeled as: 1) 6" FEMORAL ARTERIAL LINE KIT- ICU, Pack Number ART245C; 2) CHEST TUBE INSER… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-3026-2024 |
Medline Convenience kits labeled as: KIT,ER SUTURE #1, Pack Number DYNDS1130A |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-3025-2024 |
Medline Convenience kits labeled as: 1) MINOR BASIC PACK-LF, Pack Number DYNJ0281516M; 2) MINOR ACUTE PACK-LF, Pack… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-3024-2024 |
Medline Convenience kits labeled as: 1) PREP TRAY, Pack Number DYNDA1540; 2) STERILE PREP TRAY , Pack Number DYNDA2… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-3023-2024 |
Medline Convenience kits labeled as: 1) CENTRAL LINE CDS, Pack Number CDS930092U ; 2) SMALL WOUND TRAY, Pack Number D… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-3022-2024 |
Medline Convenience kits labeled as: SCS-LF, DYNJ902314D |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-3021-2024 |
Medline Convenience kits labeled as: 1) ECMO INSERTION BUNDLE W/O CANNULA, Pack Number CVI4915; 2) PORT ACCESS TRAY… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-3020-2024 |
Medline Convenience kits labeled as: 1) PRESSURE TUBING B.I., Pack Number 81239; 2) M1S1109 TRADITIONAL PROCESS-LF, P… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-3019-2024 |
Medline Convenience kits labeled as: 1) MYELOGRAM PACK, Pack Number 00-399025L ; 2) BIOPSY PROCEDURE PACK , Pack Numb… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-3018-2024 |
Medline Convenience kits labeled as: 1) GER ARTH BASIN PK RFID-LF , Pack Number DYNJ0100999K ; 2) PEDIATRIC MAJOR BAS… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-3017-2024 |
Medline Convenience kits labeled as: MUNCY PACK, Pack Number DYNJ03097D |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-3016-2024 |
Medline Convenience kits labeled as: 1) CHEST EXPLORATION CDS , Pack Number CDS920066K ; 2) CHEST EXPLORATION CDS , P… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-3015-2024 |
Medline Convenience kits labeled as: 1) PSP - VAMC LONG BEACH, Pack Number 146255; 2) INSERTION TRAY, Pack Number C… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-3014-2024 |
Medline Convenience kits labeled as: PARACERVICAL PUDENDAL BLOCK TR, Pack Number DYNJRA1023 |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-3013-2024 |
Medline Convenience kits labeled as: 1) CYSTO PACK, Pack Number DYNJ42742D; 2) CYSTO PACK, Pac… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-3012-2024 |
Medline Convenience kits labeled as: 1) GB GENERAL ENDO , Pack Number CDS984155G ; 2) BAPTIST FLOYD ENDO GI KIT , P… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-3011-2024 |
Medline Convenience kits labeled as: 1) DIALYSIS CATH ACCESS KIT, Pack Number DYNDA2516B ; 2) DIALYSIS CATH ACCESS … |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-3010-2024 |
Medline Convenience kits labeled as: 1) CVC INSERTION PACK, Pack Number CVI4720A ; 2) CVC INSERTION PACK, Pack Numb… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-3009-2024 |
Medline Convenience kits labeled as: 1) GYN ENDOSCOPY KIT , Pack Number CDS981309O ; 2) GB GENERAL ENDO , Pack Numb… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-3008-2024 |
Medline Convenience kits labeled as: PUH ESOPHAGECTOMY CDS, Pack Number CDS984309I |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-3007-2024 |
Medline Convenience kits labeled as: 1) VENOUS ACCESS TRAY, Pack Number CVI4830A; 2) DIALYSIS INSERTION BUNDLE-ADD … |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-3006-2024 |
Medline Convenience kits labeled as: 1) COMPREHENSIVE PROCEDURE PACK, Pack Number 7791 ; 2) LAVH CDS, Pack Number CDS… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-3005-2024 |
Medline Convenience kits labeled as: 1) URETEROSCOPY CDS SC-LF, Pack Number CDS983922F ; 2) URETEROSCOPY TRAY-RF, P… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-3004-2024 |
Medline Convenience kits labeled as: 1) FETOSCOPY CDS-LF, Pack Number CDS840215O ; 2) BONE RETRIEVAL PART A , Pack … |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-3003-2024 |
Medline Convenience kits labeled as: 1) NHP BREAST BIOPSY PACK, Pack Number DYNJ17400B; 2) BREAST BIOPSY TRAY, Pack… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-3002-2024 |
Medline Convenience kits labeled as: 1) HEAD & NECK TRAY, Pack Number AM310B ; 2) HEAD & NECK CDS , Pack Number CDS78… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-3001-2024 |
Medline Convenience kits labeled as: 1) ZALE STEREOTACTIC CDS , Pack Number CDS983173G ; 2) ZALE OTOLOGY CDS, Pack … |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-3000-2024 |
Medline Convenience kits labeled as: TONSIL & ADENOID PACK, Pack Number DYNJ43427C |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-2999-2024 |
Medline Convenience kits labeled as: 1) OSTEOTOMY ORAL PROCEDURE, Pack Number CDS983010J ; 2) ORAL SURGERY PACK , P… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-2998-2024 |
Medline Convenience kits labeled as: 1) BIOPSY PROCEDURE PACK, Pack Number 00-400162J; 2) BIOPSY PROCEDURE TRAY , Pac… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-2997-2024 |
Medline Convenience kits labeled as: 1) PUNCTURE TRAY , Pack Number 00-401649G ; 2) PICC LINE TRAY, Pack Number 00-40… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-2996-2024 |
Medline Convenience kits labeled as: 1) DIALYSIS CATHETER INSERTION KIT, Pack Number CVI4815; 2) ANGIO PACK, Pack N… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-2995-2024 |
Medline convenience kits labeled as: 1) PERMANENT PACING, Pack Number 00-400361J ; 2) NORTON CHILDRENS CATH LAB-LF, P… |
— |
XXX |
| 2024-04-08 |
Class II
|
Ongoing |
Z-2994-2024 |
Medline Convenience kits labeled as: KIT VASCULAR IVC FILTER PLACEM, Pack Number DYKMBNDL37AH |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-2993-2024 |
Medline Convenience kits labeled as: 1) CATH LAB SPECIAL PROCEDURE, Pack Number 00-RDF036O; 2) CATH LAB SPECIAL PROCE… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-2992-2024 |
Medline convenience kits labeled as: 1) ANGIOGRAPHY DRAPE PACK, Pack Number 00-398281J ; 2) ANGIOGRAPHY DRAPE PACK, P… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-2991-2024 |
Medline Convenience kits labeled as: CARDIAC PACING PACK, Pack Number DYNJ41223 |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-2990-2024 |
Medline Convenience kits labeled as: 1) KIT MANIFOLD CSTM-NORTHRIDGE, Pack Number 129736 ; 2) KIT LEFT HEART-VA MED… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-2989-2024 |
Medline Convenience kits, labeled as: SPINAL BLOCK 22G QUINCKE 5S BU, Pack Number DYNJRA9026 |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-2988-2024 |
Medline Convenience kits, labeled as: 1) NERVE BLOCK TRAY-LF, Pack Number DYNJRA0377B; 2) PERIPHERAL NERVE BLOCK, P… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-2987-2024 |
Medline Convenience kits, labeled as: 1) SINGLE SHOT EPIDURAL PACK-LF, Pack Number DYNJ0708470K ; 2) EPIDURAL CSTM PA… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-2986-2024 |
Medline Convenience kits labeled as: 1) STERILE LIDOCAINE SYRINGE PACK, Pack Number DYNDM1076A ; 2) PEDIATRIC EP PA… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-2985-2024 |
Medline Convenience kits, labeled as: 1) DYNJ39451D , Pack Number HOOD PACK ; 2) DYNJ59573A , Pack Number ICU RESPI… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-2984-2024 |
Medline Convenience kits, labeled as: 1) TRACHEOTOMY TRAY, Pack Number DYNDA1894; 2) TRACHEOSTOMY, Pack Number DYNJ… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-2983-2024 |
Medline Convenience kits, labeled as: 1) GAS SAM LINE .06ID 10FT MM FLT, Pack Number 35772 ; 2) ANES CIRC 90 EXP PE… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-2982-2024 |
Medline Convenience kits, labeled as: 1) TRACH CDS-LF , Pack Number CDS983142B ; 2) MER TRACH CDS , Pack Number CD… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-2981-2024 |
Medline Convenience kits, labeled as: 1) TRACHEOTOMY TRAY, Pack Number DYNDA1894; 2) ULTRASOUND GUIDED PIV KIT, Pac… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-2780-2024 |
Centurion procedure packs, containing Caina syringes, labeled as: 1) BREAST BIOPSY KIT, Pack Number DYNDH1512A; 2)… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-2779-2024 |
Centurion procedure packs, containing Caina syringes, labeled as: 1) ARTHROGRAM TRAY, Pack Number MNS11965A; 2) CI… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-2778-2024 |
Centurion procedure packs, containing Caina syringes, labeled as: SHAVE KIT, Pack Number MNS8250 |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-2777-2024 |
Centurion procedure packs, containing Caina syringes, labeled as: 1) CIRCUMCISION TRAY, Pack Number CIT6860A; 2) R… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-2776-2024 |
Centurion procedure packs, containing Caina syringes, labeled as: 1) ARTHROGRAM, Pack Number DYNDH1446A; 2) ARTHRO… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-2775-2024 |
Centurion procedure packs, containing Caina syringes, labeled as: 1) ARTHROGRAPH TRAY, Pack Name MNS12670A; 2) BREAS… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-2774-2024 |
Centurion procedure packs, containing Caina syringes, labeled as: 1) NICU CIRCUMCISION TRAY W/OUT CLAMP, Pack Number … |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-2773-2024 |
Centurion procedure packs, labeled as: 1) BIOPSY TRAY-LF, Pack Number SPEC4380; 2) CIRCUMCISION TRAY, Pack Number C… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-2772-2024 |
Centurion procedure kits, labeled as: 1) ARTHROGRAM TRAY, Pack Number DYNDH1349; 2) ARTHROGRAM TRAY-LF, Pack Number… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-2771-2024 |
Centurion procedure kits, labeled as: 1) BREAST BIOPSY KIT, Pack Number MNS6950A; 2) BREAST BIOPSY PACK, Pack numb… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-2770-2024 |
Centurion procedure kits labeled as: 1) BONE MARROW TRAY, Pack Number SPEC0255; 2) CT/ULTRASOUND BIOPSY, Pack Numbe… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-2769-2024 |
Centurion procedure kits labeled as: UMBILICAL VESSEL TRAY, Pack Number UVT1100 |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-2768-2024 |
Centurion procedure kits labeled as: 1) 3" RADIAL ARTERIAL LINE KIT- ICU, Pack Number ART240B; 2) 5FR 2L PICC LINE TR… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-2767-2024 |
Centurion procedure kits, labeled as: 1) 6" FEMORAL ARTERIAL LINE KIT- ICU, Pack Number ART245C; 2) ARTERIAL LINE T… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-2766-2024 |
Centurion procedure kits labeled as: 1) BIOPSY KIT, Pack Number DYNDA1466A; 2) BIOPSY SKIN/LACERATION TRAY, Pack Nu… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-2765-2024 |
Medline procedural kits labeled as: 1) AFCH ANTERIOR SEGMENT PK, Pack Number DYNJ63330B ; 2) ANTERIOR HIP PACK , Pa… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-2764-2024 |
Medline procedural kits labeled as: 1) ALL DOC EYE PACK, Pack Number DYNJ51654A ; 2) ASC CATARACT PACK , Pack Number … |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-2763-2024 |
Medline procedural kits labeled as: 1) LEEP PACK, Pack Number DYNJ40348G; 2) TRAB BUCKLE DSC, Pack Number DYNJ63036… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-2762-2024 |
Medline procedural kits labeled as: 1) SR C SECTION, Pack Number DYNJ908584; 2) SR C SECTION, Pack Number DYNJ908584A… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-2761-2024 |
Medline Procedure kits labeled as: 1) CIRCUMCISION SET, Pack Number CIT6335; 2) CIRCUMCISION TRAY , Pack Number CIT… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-2760-2024 |
Medline procedural kits labeled as: 1) INFANT DELIVERY KIT , Pack Number DYKM1426; 2) SR OB DELIVERY , Pack Number … |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-2759-2024 |
Medline procedural kits labeled as: NEURO TRAY, Pack Number DYNJ55909B |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-2758-2024 |
Medline procedural kits labeled as: 1) GLMI ARTHROGRAM KIT:PCL, Pack Number SPEC0300B; 2) MERCY MEDICAL CIRCUMCISIO… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-2757-2024 |
Medline procedural kits labeled as: 1) BABY ADMIT, Pack Number DYKB1011C; 2) BABY ADMIT KIT W/ PAMPERS, Pack Number… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-2756-2024 |
Medline procedural kits labeled as: 1) CIRCUMCISION TRAY, Pack Number CIT6715; 2) NICU CIRCUMCISION TRAY W/OUT CLAM… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-2755-2024 |
Medline procedural kits labeled as: 1) CIRCUMCISION TRAY, Pack Number CIT6715; 2) NICU CIRCUMCISION TRAY W/OUT CLAMP… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-2754-2024 |
Medline procedural kits labeled as: ARTHROGRAPH TRAY, Pack Number MNS12670A |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-2753-2024 |
Medline procedural kits labeled as: UMBILICAL LINE KIT W/FOAM, Pack Number DYNDL1588A |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-2752-2024 |
Medline procedural kits labeled as: 1) ARTHROGRAM TRAY, Pack Number MNS11965A; 2) ARTHROGRAPH TRAY, Pack Number MNS… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-2751-2024 |
Medline procedural kits labeled as: 1) DRAWER 3 LAB DRAW & IV START, Pack Number ACC010417 ; 2) DRAWER 3 LAB DRAW &… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-2750-2024 |
Medline procedural kits labeled as: 1) BOTOX KIT - CHRONIC MIGRAINE, Pack Number DYKM2000; 2) BREAST, Pack Number D… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-2749-2024 |
Medline procedural kits labeled as: CIRCUMCISION TRAY, Pack Number DYNDA2271 |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-2748-2024 |
Medline procedural kits labeled as: 1) FETAL SURGERY-LF, Pack Number CDS840214Q; 2) FETAL SURGERY CDS-LF, P… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-2747-2024 |
Medline procedural kits labeled as: 1) TYMPANOPLASTY , Pack Number CDS980203S; 2) MAJOR EAR , Pack Number CDS982016… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-2746-2024 |
Medline procedural kits labeled as: 1) BIOPSY PACK, Pack Number DYNJ63370A; 2) CIRCUMCISION TRAY, Pack Number CIT72… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-2745-2024 |
Medline procedural kits labeled as: 1) CAROTID ENDARTERECTOMY PK, Pack Number DYNJ85516; 2) PICC INSERTION TRA… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-2744-2024 |
Medline procedural kits labeled as: 1) MEDICAL CIRCUMCISION TRAY, Pack Number CIT6780; 2) NICU CIRCUMCISION TRAY W/… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-2743-2024 |
Medline procedural kits labeled as: 1) OPEN HEART PEDS, Pack Number CDS981050Q; 2) OPEN HEART CDS, Pack Number CDS9… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-2742-2024 |
Medline procedural kits labeled as: 1) PERIPHERAL ULTRASOUND CATHETER INSERTION, Pack Number MNS9865; 2) CIRCUMCISI… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-2741-2024 |
Medline procedural kits labeled as: PREOP NERVE BLOCK TRAY, Pack Number DYNJRA2040H |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-2740-2024 |
Medline procedural kits labeled as: 1) BABY CARE KIT UNIV, Pack Number DYKL1025; 2) BABY CARE KIT UNIV, Pack Number… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-2739-2024 |
Medline procedural kits labeled as: 1) ANESTHESIA CIRCUIT PEDS-LF, Pack Number DYNJAA0327F; 2) ANESTHESIA CIRCUIT P… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-2635-2024 |
Medline Convenience kits, labeled as: 1) NERVE STIMULATOR, Pack Number CDS981579O ; 2) DR DIULUS INJECTION PACK, Pack… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-2634-2024 |
Medline convenience kits, labeled as: 1) PAIN SERVICES CDS , Pack Number CDS985445B ; 2) PAIN SERVICES CDS , Pack Numb… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-2633-2024 |
Medline procedure packs containing Shenli syringes, labeled as follows: NEURO ANGIO PACK, Pack Number DYNDA1431A |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-2632-2024 |
Medline procedure packs containing Shenli syringes, labeled as follows: 1) NEURO ANGIO PACK, Part Number DYNDA1431A; … |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-2631-2024 |
Medline procedure packs containing Shenli syringes, labeled as follows: 1) CVC DOUBLE LUMEN 16CM, Pack Number ECVC810… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-2630-2024 |
Medline procedure packs containing Shenli syringes, labeled as follows: 1) DIALYSIS CATH ACCESS KIT, Pack Number DYNDA2… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-2629-2024 |
Medline procedure packs containing Shenli syringes, labeled as follows: 1) CVC INSERT BUNDLE 16CM, Pack Number ECVC32… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-2628-2024 |
See RES description |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-2627-2024 |
Medline procedure packs containing Shenli syringes, labeled as follows: 1) ANGIOGRAPHY DRAPE PACK, Pack Number 00-398281… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-2626-2024 |
See RES description |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-2625-2024 |
See RES Description |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-2624-2024 |
see RES for description |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-2623-2024 |
Medline procedure packs containing Shenli syringes, labeled as follows: 1) LOCAL PACK, pack number DYNJ34129C, 2) … |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-2516-2024 |
Centurion procedure kits labeled as: 1) CVC INSERT BUNDLE 16CM, Pack Number ECVC3260; 2) CVC DOUBLE LUMEN 16CM, Pac… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-2515-2024 |
Centurion procedure kits labeled as NEURO ANGIO PACK, Pack Number DYNDA1431A |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class I
|
Ongoing |
Z-2444-2024 |
Medline procedure kits labeled as: 1) WMC HYBRID OR PACK PART 1 , Pack Number CMPJ08068F ; 2) VASCULAR PACK , Pack … |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class I
|
Ongoing |
Z-2443-2024 |
Medline procedure kits labeled as: 1) NEPHROLOGY PACK, Pack Number DYNJ59089; 2) NERVE BLOCK TRAY, P… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-04-08 |
Class I
|
Ongoing |
Z-2442-2024 |
Medline procedure kits labeled as: 1) CONTINUOUS BLOCK, Pack Number DYNJRA0960C; 2) COMBINED SPINAL AND EPIDURAL, P… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-03-22 |
Class II
|
Ongoing |
Z-2714-2024 |
Medline medical procedure kits labeled as follows: a) ARTHROSCOPY, REF DYNJ909699; b) BACK CDS, REF CDS984000C; c… |
— |
A slight dimensional variation which has the potential for increased difficulty fitting into outer canister. |
| 2024-03-22 |
Class II
|
Ongoing |
Z-2713-2024 |
Medline medical procedure kits labeled as follows: a) C-SECTION CDS, REF CDS983998C |
— |
A slight dimensional variation which has the potential for increased difficulty fitting into outer canister. |
| 2024-03-22 |
Class II
|
Ongoing |
Z-2712-2024 |
Medline medical procedure kits labeled as follows: a) GYN CDS, REF DYNJ905499B; b) GYN LAP, REF DYNJ909936; c) GY… |
— |
A slight dimensional variation which has the potential for increased difficulty fitting into outer canister. |
| 2024-03-22 |
Class II
|
Ongoing |
Z-2711-2024 |
Medline medical procedure kits labeled as follows: a) BASIC NEURO, REF DYNJ909171A; b) NEURO, REF DYNJ905510D; c)… |
— |
A slight dimensional variation which has the potential for increased difficulty fitting into outer canister. |
| 2024-03-22 |
Class II
|
Ongoing |
Z-2710-2024 |
Medline medical procedure kits labeled as follows: a) TURNOVER KIT, REF DYKC1289F |
— |
A slight dimensional variation which has the potential for increased difficulty fitting into outer canister. |
| 2024-03-22 |
Class II
|
Ongoing |
Z-2709-2024 |
Medline medical procedure kits labeled as follows: a) KIT CANISTER SUCT W 12FT, REF DYKM2169 |
— |
A slight dimensional variation which has the potential for increased difficulty fitting into outer canister. |
| 2024-03-22 |
Class II
|
Ongoing |
Z-2708-2024 |
Medline medical procedure kits labeled as follows: a) AAA CDS, REF CDS984011C; b) CAN KIT, REF DYKM1184; c) DENTA… |
— |
A slight dimensional variation which has the potential for increased difficulty fitting into outer canister. |
| 2024-03-22 |
Class II
|
Ongoing |
Z-2707-2024 |
Medline medical procedure kits labeled as follows: a) MAJOR BREAST, REF DYNJ905004C; b) MINOR BREAST, REF DYNJ90500… |
— |
A slight dimensional variation which has the potential for increased difficulty fitting into outer canister. |
| 2024-03-22 |
Class II
|
Ongoing |
Z-2706-2024 |
Medline medical procedure kits labeled as follows: a) ENDO KIT, REF DYKE1410A |
— |
A slight dimensional variation which has the potential for increased difficulty fitting into outer canister. |
| 2024-03-22 |
Class II
|
Ongoing |
Z-2705-2024 |
Medline medical procedure kits labeled as follows: a) ENDO KIT, REF DYK1012268E1 |
— |
A slight dimensional variation which has the potential for increased difficulty fitting into outer canister. |
| 2024-03-22 |
Class II
|
Ongoing |
Z-2704-2024 |
Medline medical procedure kits labeled as follows: a) CYSTO, REF DYNJ905000D; b) ENDO KIT, REF DYKE1462A; c) ENDO… |
— |
A slight dimensional variation which has the potential for increased difficulty fitting into outer canister. |
| 2024-03-22 |
Class II
|
Ongoing |
Z-2703-2024 |
Medline medical procedure kits labeled as follows: a) BASIC NASAL, REF DYNJ909932; b) BRONCH KIT, REF DYKE1007B; … |
— |
A slight dimensional variation which has the potential for increased difficulty fitting into outer canister. |
| 2024-03-22 |
Class II
|
Ongoing |
Z-2702-2024 |
Medline medical procedure kits labeled as follows: DENTAL, REF DYNJ909211A |
— |
A slight dimensional variation which has the potential for increased difficulty fitting into outer canister. |
| 2024-03-22 |
Class II
|
Ongoing |
Z-2701-2024 |
Medline medical procedure kits labeled as follows: a) HEART ANESTHESIA SET UP, REF DYNJ902752C, b) KIT ENDO, REF DY… |
— |
A slight dimensional variation which has the potential for increased difficulty fitting into outer canister. |
| 2024-03-22 |
Class II
|
Ongoing |
Z-2700-2024 |
Medline medical procedure kits labeled as follows: a) ANESTHESIA CIRCUIT ADULT, REF DYNJAAF6666B; b) ANESTHESIA CIR… |
— |
A slight dimensional variation which has the potential for increased difficulty fitting into outer canister. |
| 2024-03-22 |
Class II
|
Ongoing |
Z-2699-2024 |
1,5L MED-SOFT SINGLE LINER WITH SOLIDIFIER, REF OR1920PG |
— |
A slight dimensional variation which has the potential for increased difficulty fitting into outer canister. |
| 2024-03-22 |
Class II
|
Ongoing |
Z-2698-2024 |
1,5L MED-SOFT LINER W/ 6MMX3M TUB. & ADULT VC, REF OR53929 |
— |
A slight dimensional variation which has the potential for increased difficulty fitting into outer canister. |
| 2024-03-22 |
Class II
|
Ongoing |
Z-2697-2024 |
1,5L MED-SOFT LINER W/ 6MMX1,8M TUB. & ADULT VC, REF OR53926 |
— |
A slight dimensional variation which has the potential for increased difficulty fitting into outer canister. |
| 2024-03-22 |
Class II
|
Ongoing |
Z-2696-2024 |
1500ML SOFT LINER, 1/4X6 TBG NS, REF OR926K |
— |
A slight dimensional variation which has the potential for increased difficulty fitting into outer canister. |
| 2024-03-22 |
Class II
|
Ongoing |
Z-2695-2024 |
LINER, SOFT, SUCTION CANISTER, 1500CC, REF OR929K |
— |
A slight dimensional variation which has the potential for increased difficulty fitting into outer canister. |
| 2024-03-22 |
Class II
|
Ongoing |
Z-2694-2024 |
LINER, SOFT, SUCTION CANISTER, 1500CC, REF DYNDSCL1500 |
— |
A slight dimensional variation which has the potential for increased difficulty fitting into outer canister. |
| 2024-03-14 |
Class II
|
Ongoing |
Z-2232-2024 |
Non-sterile convenience kits: a. Medline CC Drawer 4 IV Circulation, Pack #ACC010254B, containing a Pure Pouch compon… |
— |
Surgical convenience kits containing Pure Pouch component that has weak seals which may result in a breach in sterility of the contents if the seal fails. |
| 2024-03-14 |
Class II
|
Ongoing |
Z-2231-2024 |
Non-sterile convenience kits: Medline Open Heart CDS, Pack #CDS981759C, containing a Pure Pouch with component Reorde… |
— |
Surgical convenience kits containing Pure Pouch component that has weak seals which may result in a breach in sterility of the contents if the seal fails. |
| 2024-03-14 |
Class II
|
Ongoing |
Z-2230-2024 |
Non-sterile convenience kits: a. Medline Difficult Airway Tray W/O Cook, Pack #ACC010578, containing a Pure Pouch wi… |
— |
Surgical convenience kits containing Pure Pouch component that has weak seals which may result in a breach in sterility of the contents if the seal fails. |
| 2024-03-14 |
Class II
|
Ongoing |
Z-2229-2024 |
Nonsterile convenience kits: a. Medline Delivery, Pack #DYNJ901130I, containing a Pure Pouch with component Reorder … |
— |
Surgical convenience kits containing Pure Pouch component that has weak seals which may result in a breach in sterility of the contents if the seal fails. |
| 2024-03-14 |
Class II
|
Ongoing |
Z-2228-2024 |
Sterile convenience kits: a. Medline Retrograde PK-22025203-LF, Pack #DYNJ47873K, containing a Pure Pouch containing… |
— |
Surgical convenience kits containing Pure Pouch component that has weak seals which may result in a breach in sterility of the contents if the seal fails. |
| 2024-03-14 |
Class II
|
Ongoing |
Z-2227-2024 |
Sterile convenience kit: Medline Birthing Room Pack, Pack #DYNJ38429D, containing a Pure Pouch component Sterile Shar… |
— |
Surgical convenience kits containing Pure Pouch component that has weak seals which may result in a breach in sterility of the contents if the seal fails. |
| 2024-03-14 |
Class II
|
Ongoing |
Z-2226-2024 |
Sterile surgical convenience kit: Medline Neuro IR Pack, Pack #DYNJ56073C, containing a Pure Pouch with component Me… |
— |
Surgical convenience kits containing Pure Pouch component that has weak seals which may result in a breach in sterility of the contents if the seal fails. |
| 2024-03-14 |
Class II
|
Ongoing |
Z-2225-2024 |
Sterile surgical convenience kit: Medline Retrograde PK-22025203-LF, Pack #DYNJ47873L, containing a Pure Pouch with c… |
— |
Surgical convenience kits containing Pure Pouch component that has weak seals which may result in a breach in sterility of the contents if the seal fails. |
| 2024-03-14 |
Class II
|
Ongoing |
Z-2224-2024 |
Sterile surgical convenience kits: a. Medline Cath Lab Special Procedure, Pack #00-RDF0360, containing a Pure Pouch… |
— |
Surgical convenience kits containing Pure Pouch component that has weak seals which may result in a breach in sterility of the contents if the seal fails. |
| 2024-03-12 |
Class II
|
Ongoing |
Z-1807-2024 |
Namic FLUID DELIVERY SET, REF 91300040 |
— |
Products have a lack of sterility assurance. |
| 2024-03-12 |
Class II
|
Ongoing |
Z-1806-2024 |
namic CONVENIENCE KIT, a) CAROTID MANIFOLD KIT, REF 60011045; b) 3V MANIFOLD KIT ON WITH NAMIC DT & WASTE MANAGEMENT… |
— |
Products have a lack of sterility assurance. |
| 2024-03-05 |
Class II
|
Ongoing |
Z-1488-2024 |
Bed Assist Bars, labeled as follows: a) Medline SwivAssist Bar, Model Number MDS6800SWIV (case of 3), b) Medline Sw… |
— |
Medline is recalling certain lots of our Adult Portable Bed Rails that were manufactured after the mandatory compliance requirement (ASTM F3186-17, Standard Sp… |
| 2024-03-05 |
Class II
|
Ongoing |
Z-1487-2024 |
Bed Assist Bars, labeled as follows: a) Medline, Model Number BA6800, b) Medline Martha Stewart, Model Number MDS68… |
— |
Medline is recalling certain lots of our Adult Portable Bed Rails that were manufactured after the mandatory compliance requirement (ASTM F3186-17, Standard Sp… |
| 2024-03-01 |
Class II
|
Ongoing |
Z-1918-2024 |
Medline medical procedure kits, labeled as follows: a) PARACERVICAL PUD TRAY, REF DYNDH1832; b) AHS PARACERVICAL/PU… |
— |
Trumpet Needle Guide ring can detach when excessive pressure is applied. |
| 2024-03-01 |
Class II
|
Ongoing |
Z-1917-2024 |
Centurion OB INSTRUMENT TRAY, REF MN3925; Medical procedure convenience tray |
— |
Trumpet Needle Guide ring can detach when excessive pressure is applied. |
| 2024-02-26 |
Class I
|
Ongoing |
Z-1876-2024 |
Medline Sub-G Endotracheal Tube with Subglottic Suctioning: (1) REF DYNJ18860, Polyurethane Cuff 6.0 mm ID; (2) REF … |
— |
Complaints have been received that the device inflation tube detached and/or tore from the main tube, resulting in potential moisture buildup, loss of pressure,… |
| 2024-02-26 |
Class II
|
Ongoing |
Z-1459-2024 |
Blood Pressure Unit, Model (REF) Numbers: a) MDS4001, b) MDS4001LA, c) MDS4001PLUS |
— |
The firm provided a set of specifications for the device, but some units of the device were manufactured non-compliant with the specifications. However, the fir… |
| 2024-02-23 |
Class II
|
Ongoing |
Z-1455-2024 |
MEDLINE SWABSTICKS ALCOHOL 3PK, Product code DYNDA2723 |
— |
Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users. |
| 2024-02-23 |
Class II
|
Ongoing |
Z-1454-2024 |
MEDLINE 4.5 IN WIRE CUT SCISSORS, Product Code DYND04006 |
— |
Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users. |
| 2024-02-23 |
Class II
|
Ongoing |
Z-1453-2024 |
MEDLINE SWABSTICKS PVP 3 PK, Product Code DYNDA2724 |
— |
Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users. |
| 2024-02-23 |
Class II
|
Ongoing |
Z-1452-2024 |
MEDLINE M1S0179 STRL TAPE/PEN PACK, Product Code P519582A |
— |
Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users. |
| 2024-02-23 |
Class II
|
Ongoing |
Z-1451-2024 |
Centurion DISP.UMBILICAL CORD CLAMP CUTTER(CTR300), Product Code 67335 |
— |
Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users. |
| 2024-02-23 |
Class II
|
Ongoing |
Z-1450-2024 |
Centurion Manual surgical kits labeled as: a) HEGAR UTERINE DILATOR, 11-12MM, STERILE, Product Code HUD112ST; b) ST… |
— |
Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users. |
| 2024-02-23 |
Class II
|
Ongoing |
Z-1449-2024 |
Centurion Manual surgical kits labeled as: a) STERILE S/B WIRE SCISSOR, Product Code 65140; b) SHARP/SHARP SCISSORS… |
— |
Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users. |
| 2024-02-23 |
Class II
|
Ongoing |
Z-1448-2024 |
Centurion Manual surgical kits labeled as: a) 15ML SAMPLING TUBE WITH CAP, Product Code 15MLVLCP; b) STERILE 9X12 R… |
— |
Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users. |
| 2024-02-23 |
Class II
|
Ongoing |
Z-1447-2024 |
Centurion PICC LINE SECUREMENT KIT, Product Code IVS565 |
— |
Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users. |
| 2024-02-23 |
Class II
|
Ongoing |
Z-1446-2024 |
Centurion STERILE #16 RUBBER BAND, Product Code EB16 |
— |
Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users. |
| 2024-02-23 |
Class II
|
Ongoing |
Z-1445-2024 |
Centurion manual surgical kits labeled as: a) SUTURE REMOVAL TRAY, Product Code TRI55405; b) SUTURE REMOVAL SET, Prod… |
— |
Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users. |
| 2024-02-23 |
Class II
|
Ongoing |
Z-1444-2024 |
Centurion manual surgical kits labeled as: a) STERILE 4-1/2" S/S SCISSOR (SS5031), Product Code 65145; b) STERILE S/… |
— |
Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users. |
| 2024-02-23 |
Class II
|
Ongoing |
Z-1443-2024 |
Centurion manual surgical kits labeled as: a) STERILE ALLIS TISS FCP 10", Product Code I68905; b) VAGINAL REPAIR KIT… |
— |
Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users. |
| 2024-02-23 |
Class II
|
Ongoing |
Z-1442-2024 |
Centurion manual surgical kits labeled as: a) ST. VIRTUS SPLINTER FORCEP 6" (SF8246), Product Code 66580; b) DEBRIDE… |
— |
Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users. |
| 2024-02-23 |
Class II
|
Ongoing |
Z-1441-2024 |
Centurion manual surgical kits labeled as: a) STERILE TUBE OCCLUDING FORCEP (TO8256), Product Code 66225; b) ST. KEL… |
— |
Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users. |
| 2024-02-23 |
Class II
|
Ongoing |
Z-1440-2024 |
Centurion Clamp kits labeled as: a) STERILE BACKHAUS TOWEL CLAMP (BTC173), Product Code 66520; b) STERILE TOWEL CLAM… |
— |
Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users. |
| 2024-02-23 |
Class II
|
Ongoing |
Z-1439-2024 |
Centurion Curette kits labeled as: a) STERILE BUCK EAR CURETTE "00" (25697), Product Code 66745; b) STERILE "1" EAR … |
— |
Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users. |
| 2024-02-23 |
Class II
|
Ongoing |
Z-1438-2024 |
Centurion Hemostat kits labeled as: a) STERILE CURV KELLY HEMOSTAT, Product Code 65340; b) STERILE CURV MOSQUITO HEM… |
— |
Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users. |
| 2024-02-23 |
Class II
|
Ongoing |
Z-1437-2024 |
Centurion Forcep kits labeled as: a) STERILE F/P SPLINTER FORCEP (SF6141), Product Code 66165; b) STERILE WEBSTER NEED… |
— |
Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users. |
| 2024-02-23 |
Class II
|
Ongoing |
Z-1436-2024 |
Centurion scalpel handle kits labeled as: a) STERILE # 3 SCALPEL HANDLE, Product Code 66825; b) STERILE PAS #3 BLADE … |
— |
Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users. |
| 2024-02-23 |
Class II
|
Ongoing |
Z-1435-2024 |
Centurion hook kits labeled as: a) STERILE SKIN HOOK FINE (EA3975F), Product Code 66660; b) STERILE SMALL 2 PRONG SKI… |
— |
Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users. |
| 2024-02-23 |
Class II
|
Ongoing |
Z-1434-2024 |
Centurion retractor kits labeled as: a) STERILE 6-1/2" SENN RETRACTOR (ST7185), Product Code 66795; b) STERILE RAGNEL… |
— |
Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users. |
| 2024-02-23 |
Class II
|
Ongoing |
Z-1433-2024 |
Centurion STERILE ROUND EAR SPECULUM SET (3, 4, 5), Product Code I68505 |
— |
Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users. |
| 2024-02-23 |
Class II
|
Ongoing |
Z-1432-2024 |
Centurion STERILE #5 LARYNGEAL MIRROR(505709), Product Code 67830 |
— |
Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users. |
| 2024-02-23 |
Class II
|
Ongoing |
Z-1431-2024 |
Centurion kits: a) DENTAL INSTRUMENT KIT, Product Code DH760; b) STERILE COTTON DENTAL ROLLS 6/PK, Product Code 9125S… |
— |
Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users. |
| 2024-02-23 |
Class II
|
Ongoing |
Z-1430-2024 |
Centurion STERILE BLOOD COLLECTION TUBE,10ML, Product Code 6430ST |
— |
Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users. |
| 2024-02-23 |
Class II
|
Ongoing |
Z-1429-2024 |
Centurion STERILE COTTON DENTAL ROLLS 6/PK, Product Code 9125ST6 |
— |
Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users. |
| 2024-02-23 |
Class II
|
Ongoing |
Z-1428-2024 |
Centurion FCP MAGILL CATH 7.5 IN PED (67575), Product Code 67575 |
— |
Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users. |
| 2024-02-23 |
Class II
|
Ongoing |
Z-1427-2024 |
Centurion STERILE TRACH BRUSH, Product Code 6225ST |
— |
Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users. |
| 2024-01-23 |
Class II
|
Ongoing |
Z-1295-2024 |
CVS Health Waterproof Wound Tracking Dressing, REF CVS690330, immediate package contains 1 sterile dressing, 4 in. x 4 i… |
— |
Product failed sterility testing. |
| 2024-01-04 |
Class II
|
Ongoing |
Z-1157-2024 |
Medline Contro-Bulb Syringe, REF DYND20125; bulb irrigation syringe |
— |
Packaging material was updated for the Bulb Irrigation Syringe (DYND20125), and additional testing done at Medline Corporate indicated the potential for the ste… |
| 2023-12-21 |
Class II
|
Ongoing |
Z-0969-2024 |
MEDLINE BLOOD CULTURE TRAY ADULT, Reorder Number DYNDH1194A |
— |
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Various Adult Blood and Blood Culture Kits. This recall is due to kits built using… |
| 2023-12-21 |
Class II
|
Ongoing |
Z-0968-2024 |
MEDLINE BLOOD CULTURE KIT, Reorder Number DYNDH1622C |
— |
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Various Adult Blood and Blood Culture Kits. This recall is due to kits built using… |
| 2023-12-21 |
Class II
|
Ongoing |
Z-0967-2024 |
MEDLINE BLOOD CULTURE KIT, Reorder Number DYNDH1723 |
— |
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Various Adult Blood and Blood Culture Kits. This recall is due to kits built using… |
| 2023-12-21 |
Class II
|
Ongoing |
Z-0966-2024 |
MEDLINE BLOOD CULTURE COLLECTION KIT, Reorder Number DYNDH1626B |
— |
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Various Adult Blood and Blood Culture Kits. This recall is due to kits built using… |
| 2023-12-21 |
Class II
|
Ongoing |
Z-0965-2024 |
MEDLINE BLOOD CULTURE COLLECTION KIT, Reorder Number DYNDH1714A |
— |
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Various Adult Blood and Blood Culture Kits. This recall is due to kits built using… |
| 2023-12-21 |
Class II
|
Ongoing |
Z-0964-2024 |
MEDLINE BLOOD CULTURE BOTTLE KIT, Reorder Number DYNDH1738A |
— |
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Various Adult Blood and Blood Culture Kits. This recall is due to kits built using… |
| 2023-12-21 |
Class II
|
Ongoing |
Z-0963-2024 |
MEDLINE ADULT BLOOD CULTURE KIT, Reorder Number DYNDH1694A |
— |
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Various Adult Blood and Blood Culture Kits. This recall is due to kits built using… |
| 2023-12-20 |
Class II
|
Ongoing |
Z-1180-2024 |
These wipes are saturated with 0.65% bleach solution. These wipes are antimicrobial, disinfectant with sporicidal, viruc… |
— |
There is stability concern for products dated with a 24-month shelf life. Product is safe and effective up to 12 months shelf life. |
| 2023-11-29 |
Class II
|
Ongoing |
Z-0711-2024 |
Medline Gown Poly W/Breath Sleeves XL AAMIK Level 4 (Eclipse gown), REF SPT-2208CS, 100/pack, Non-Sterile. |
— |
Surgical gowns were manufactured with the wrong sleeve. |
| 2023-11-15 |
Class I
|
Ongoing |
Z-1138-2024 |
Centurion Kits, trays, and packs labeled as follows: CIRCUMCISION TRAY, REF DYNDA2271 |
— |
Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irr… |
| 2023-11-15 |
Class I
|
Ongoing |
Z-1137-2024 |
Centurion Kits, trays, and packs labeled as follows: BREAST BIOPSY KIT, REF MNS4360 |
— |
Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irr… |
| 2023-11-15 |
Class I
|
Ongoing |
Z-1136-2024 |
Centurion Kits, trays, and packs labeled as follows: a) A C DAILY WET KIT, REF DM405A; b) BWH DAILY DRIVELINE MGMT … |
— |
Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irr… |
| 2023-11-15 |
Class I
|
Ongoing |
Z-1135-2024 |
Centurion Kits, trays, and packs labeled as follows: LACERATION TRAY, REF ST11670A |
— |
Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irr… |
| 2023-11-15 |
Class I
|
Ongoing |
Z-1134-2024 |
Centurion Kits, trays, and packs labeled as follows: a) IV SECUREMENT KIT, REF IVS1860B; b) NEONATAL PICC LINE INSE… |
— |
Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irr… |
| 2023-11-15 |
Class I
|
Ongoing |
Z-1133-2024 |
Centurion Kits, trays, and packs labeled as follows: LATEX FREE TRACHEOSTOMY CARE TRAY, REF TC7170 |
— |
Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irr… |
| 2023-11-15 |
Class I
|
Ongoing |
Z-1132-2024 |
Centurion Kits, trays, and packs labeled as follows: a) BASIC PROCEDURE TRAY, REF MNS13600; b) BWH DAILY DRIVELINE … |
— |
Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irr… |
| 2023-11-15 |
Class I
|
Ongoing |
Z-1131-2024 |
Centurion Kits, trays, and packs labeled as follows: EYE PREP KIT, REF ET1010 |
— |
Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irr… |
| 2023-11-15 |
Class I
|
Ongoing |
Z-1130-2024 |
Centurion Kits, trays, and packs labeled as follows: a) DIALYSIS ACCESSORY PACK W/O CATHETER, REF MNS10750A; b) DIA… |
— |
Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irr… |
| 2023-11-15 |
Class I
|
Ongoing |
Z-1129-2024 |
Centurion Kits, trays, and packs labeled as follows: MAINTENANCE FLUSH KIT/BLOOD DRAW, REF DT19335A |
— |
Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irr… |
| 2023-11-15 |
Class I
|
Ongoing |
Z-1128-2024 |
Medline Kits, trays, and packs labeled as follows: a) KIT,SUCTION CATH,10FR W/WATER, REF DYND41470; b) KIT,SUCTION … |
— |
Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irr… |
| 2023-11-15 |
Class I
|
Ongoing |
Z-1127-2024 |
Medline Kits, trays, and packs labeled as follows: a) ANTERIOR PACK, REF DYNJ64814A; b) ARTHROGRAM TRAY, REF DYNDH1… |
— |
Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irr… |
| 2023-11-15 |
Class I
|
Ongoing |
Z-1126-2024 |
Medline Kits, trays, and packs labeled as follows: a) CATARACT PACK, REF VAL011CTASD; b) CATARACT PACK, REF DYNJ688… |
— |
Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irr… |
| 2023-11-15 |
Class I
|
Ongoing |
Z-1125-2024 |
Medline Kits, trays, and packs labeled as follows: a) D&C CDS, REF CDS983911J; b) D&C PACK, REF DYNJ67214F; c) D&… |
— |
Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irr… |
| 2023-11-15 |
Class I
|
Ongoing |
Z-1124-2024 |
Medline Kits, trays, and packs labeled as follows: C-SECTION, REF DYNJ904653G |
— |
Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irr… |
| 2023-11-15 |
Class I
|
Ongoing |
Z-1123-2024 |
Medline Kits, trays, and packs labeled as follows: a) GYN LAPAROSCOPY, REF CDS984900M; b) GYN LAPAROSCOPY CDS, REF … |
— |
Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irr… |
| 2023-11-15 |
Class I
|
Ongoing |
Z-1122-2024 |
Medline Kits, trays, and packs labeled as follows: a) L&B CDS-LF, REF CDS980273D; b) LABOR AND DELIVERY, REF DYNJ90… |
— |
Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irr… |
| 2023-11-15 |
Class I
|
Ongoing |
Z-1121-2024 |
Medline Kits, trays, and packs labeled as follows: a) NUR 105, REF EDUC05053B; b) NUR 213, REF EDUC05054B; c) NUR… |
— |
Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irr… |
| 2023-11-15 |
Class I
|
Ongoing |
Z-1120-2024 |
Medline Kits, trays, and packs labeled as follows: WOUND CARE TRAY - LATEX-FREE, REF DYND06002 |
— |
Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irr… |
| 2023-11-15 |
Class I
|
Ongoing |
Z-1119-2024 |
Medline Kits, trays, and packs labeled as follows: a) TRACH CARE KIT, REF DYND40589; b) TRACH CARE KIT, REF DYNDA30… |
— |
Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irr… |
| 2023-11-15 |
Class I
|
Ongoing |
Z-1118-2024 |
Medline Kits, trays, and packs labeled as follows: a) ER LACERATION TRAY - SNAG FREE, REF SUT12825; b) LACERATION T… |
— |
Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irr… |
| 2023-11-15 |
Class I
|
Ongoing |
Z-1117-2024 |
Medline Kits, trays, and packs labeled as follows: a) CENTRAL LINE TRAY, REF CVI4705; b) DAILY DRIVELINE MGMT KIT w… |
— |
Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irr… |
| 2023-11-15 |
Class I
|
Ongoing |
Z-1116-2024 |
Medline Kits, trays, and packs labeled as follows: a) C L PREP, REF DYNJ69664; b) DMEK PREP PACK, REF DYNJ81659A; … |
— |
Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irr… |
| 2023-11-15 |
Class I
|
Ongoing |
Z-1115-2024 |
Medline Kits, trays, and packs labeled as follows: a) BLOOD DRAW KIT, REF DYNDV2183A; b) LCPH LAB DRAW KIT, REF DYN… |
— |
Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irr… |
| 2023-11-15 |
Class I
|
Ongoing |
Z-1114-2024 |
Medline Kits, trays, and packs labeled as follows: a) PORT REMOVAL PACK, REF DYNDA2936; b) PORT REMOVAL PACK, REF D… |
— |
Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irr… |
| 2023-11-15 |
Class I
|
Ongoing |
Z-1113-2024 |
Medline Kits, trays, and packs labeled as follows: a) PORT ACCESS TRAY, REF DYNDA2863; b) PORT ACCESS TRAY, REF DYN… |
— |
Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irr… |
| 2023-11-15 |
Class I
|
Ongoing |
Z-1112-2024 |
Medline Kits, trays, and packs labeled as follows: a) LACERATION KIT, REF SUT13935; b) LACERATION TRAY, REF SUT2121… |
— |
Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irr… |
| 2023-11-15 |
Class I
|
Ongoing |
Z-1111-2024 |
Medline Kits, trays, and packs labeled as follows: a) 709E RECOVERY PACK A,B,C II SS, REF DYNJ55960G; b) ABDOMEN PA… |
— |
Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irr… |
| 2023-11-15 |
Class I
|
Ongoing |
Z-1110-2024 |
Medline Kits, trays, and packs labeled as follows: CHP WOUND IRRIGATION KIT, REF DYK1017614W |
— |
Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irr… |
| 2023-11-15 |
Class I
|
Ongoing |
Z-1109-2024 |
Medline Kits, trays, and packs labeled as follows: a) BREAST PACK, REF DYNJ56344B; b) SEPTOPLASTY PACK WRO-LF, RE… |
— |
Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irr… |
| 2023-11-15 |
Class I
|
Ongoing |
Z-1108-2024 |
Medline Kits, trays, and packs labeled as follows: TRAY,L&D INSTRUMENT, REF DYNDL1550 |
— |
Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irr… |
| 2023-11-15 |
Class I
|
Ongoing |
Z-1107-2024 |
Centurion Kits, trays, and packs labeled as follows: a) DIALYSIS ACCESSORY PACK W/O CATHETER, REF MNS10750A; b) D… |
— |
Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irr… |
| 2023-11-15 |
Class I
|
Ongoing |
Z-1106-2024 |
MEDLINE Kits, trays, and packs labeled as follows: a) ENDO KIT, REF DYKE1350D; b) PANENDOSCOPY-LF, REF DYNJ36728C… |
— |
Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irr… |
| 2023-11-15 |
Class I
|
Ongoing |
Z-1105-2024 |
MEDLINE Kits, trays, and packs labeled as follows: DIALYSIS ON/OFF BNDLE -NO DRSG, REF DYNDC3088 |
— |
Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irr… |
| 2023-11-15 |
Class I
|
Ongoing |
Z-1104-2024 |
MEDLINE Kits, trays, and packs labeled as follows: CATHETERIZATION KIT, REF DYNDA2939 |
— |
Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irr… |
| 2023-11-15 |
Class I
|
Ongoing |
Z-1103-2024 |
MEDLINE Kits, trays, and packs labeled as follows: a) C-SECTION, REF DYNJ904653G; b) DRESSING TRAY, REF M101426; … |
— |
Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irr… |
| 2023-11-15 |
Class I
|
Ongoing |
Z-1102-2024 |
MEDLINE Kits, trays, and packs labeled as follows: a) ASC GENERAL MINOR CDS, REF CDS983673G; b) ASC GENERAL MINOR C… |
— |
Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irr… |
| 2023-11-15 |
Class I
|
Ongoing |
Z-1101-2024 |
MEDLINE Kits, trays, and packs labeled as follows: a) ASC MINOR THYROID CDS, REF CDS983682F; b) BRONCHOSCOPY KIT, R… |
— |
Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irr… |
| 2023-11-15 |
Class I
|
Ongoing |
Z-1100-2024 |
MEDLINE Kits, trays, and packs labeled as follows: SERUM TEAR KIT, REF DYNDA1545 |
— |
Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irr… |
| 2023-11-15 |
Class I
|
Ongoing |
Z-1099-2024 |
Centurion Kits, trays, and packs labeled as follows: MAINTENANCE FLUSH KIT/BLOOD DRAW, REF DT19335A |
— |
Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irr… |
| 2023-11-15 |
Class I
|
Ongoing |
Z-1098-2024 |
MEDLINE Kits, trays, and packs labeled as follows: a) Description, REF DYNDH1679; b) BREAST BIOPSY TRAY, REF DYNDH1… |
— |
Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irr… |
| 2023-11-15 |
Class I
|
Ongoing |
Z-1097-2024 |
MEDLINE Kits, trays, and packs labeled as follows: a) ARTERIAL LINE PACK, REF DYNJ65208A; b) CANCER SERVICE PORT KI… |
— |
Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irr… |
| 2023-11-15 |
Class I
|
Ongoing |
Z-1096-2024 |
MEDLINE Kits, trays, and packs labeled as follows: a) DIALYSIS FISTULA KIT, REF DYNDC3106, b) ENDO KIT, REF DYKE134… |
— |
Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irr… |
| 2023-11-15 |
Class I
|
Ongoing |
Z-1095-2024 |
MEDLINE Kits, trays, and packs labeled as follows: a) CATH LAB CDS, REF CDS840228F; b) PEDIATRIC PORT A CATH TRAY, … |
— |
Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irr… |
| 2023-11-15 |
Class I
|
Ongoing |
Z-1094-2024 |
MEDLINE ARTERIAL BUNDLE NO CATHETER, REF ART995 |
— |
Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irr… |
| 2023-11-15 |
Class I
|
Ongoing |
Z-1093-2024 |
MEDLINE BRONCHOSCOPY TRAY, REF DYNDL1350A |
— |
Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irr… |
| 2023-11-15 |
Class I
|
Ongoing |
Z-1092-2024 |
MEDLINE kits and trays, labeled as: a) SUCTION CATH 10FR KIT W/SALINE, REF DYND41470SA, DYND41470SAH; b) TRACH CARE … |
— |
Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irr… |
| 2023-11-15 |
Class I
|
Ongoing |
Z-1091-2024 |
MEDLINE TRAY care and cleaning kits and trays for Tracheostomy and Stomas, labeled as: a) STOMA & TRACH CLEANING KIT, … |
— |
Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irr… |
| 2023-11-15 |
Class I
|
Ongoing |
Z-1090-2024 |
MEDLINE TRAY TRACH BASIC SOLUTION, REF DYND40511 |
— |
Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irr… |
| 2023-11-03 |
Class II
|
Ongoing |
Z-0531-2024 |
STERILE POVIDONE, REF DYNDA2061 |
— |
The product description on the labeling includes the word "Sterile" or STRL", however the contents of the solution inside the foil sachet is non-sterile. |
| 2023-11-03 |
Class II
|
Ongoing |
Z-0530-2024 |
STERILE BETADINE, REF DYNDA1998 |
— |
The product description on the labeling includes the word "Sterile" or STRL", however the contents of the solution inside the foil sachet is non-sterile. |
| 2023-11-03 |
Class II
|
Ongoing |
Z-0529-2024 |
PVP SOLUTION SING STRL, REF DYNDA1858 |
— |
The product description on the labeling includes the word "Sterile" or STRL", however the contents of the solution inside the foil sachet is non-sterile. |
| 2023-11-03 |
Class II
|
Ongoing |
Z-0528-2024 |
STERILE PVP, REF DYNDA1649 |
— |
The product description on the labeling includes the word "Sterile" or STRL", however the contents of the solution inside the foil sachet is non-sterile. |
| 2023-11-03 |
Class II
|
Ongoing |
Z-0527-2024 |
STERILE STERILE PREP STICK, REF DYNDA1134 |
— |
The product description on the labeling includes the word "Sterile" or STRL", however the contents of the solution inside the foil sachet is non-sterile. |
| 2023-11-03 |
Class II
|
Ongoing |
Z-0526-2024 |
STERILE PVP SLN KIT, REF DYNDM1097 |
— |
The product description on the labeling includes the word "Sterile" or STRL", however the contents of the solution inside the foil sachet is non-sterile. |
| 2023-11-03 |
Class II
|
Ongoing |
Z-0525-2024 |
STERILE PVP SOLUTION, REF DYNDA1907 |
— |
The product description on the labeling includes the word "Sterile" or STRL", however the contents of the solution inside the foil sachet is non-sterile. |
| 2023-11-01 |
Class II
|
Ongoing |
Z-0314-2024 |
BLOOD CULTURE KIT, REF DYNDH1647B |
— |
This recall is being issued due to items within the kit have expired prior to the overall kit expiration date listed on the insert. |
| 2023-11-01 |
Class II
|
Ongoing |
Z-0313-2024 |
24 BLOOD CULTURE KIT, REF DYNDH1632 |
— |
This recall is being issued due to items within the kit have expired prior to the overall kit expiration date listed on the insert. |
| 2023-11-01 |
Class II
|
Ongoing |
Z-0312-2024 |
CENTRAL LINE BLOOD CULTURE DRA, REF DYNDH1562 |
— |
This recall is being issued due to items within the kit have expired prior to the overall kit expiration date listed on the insert. |
| 2023-11-01 |
Class II
|
Ongoing |
Z-0311-2024 |
PERIPHERAL BLOOD CULTURE DRAW, REF DYNDH1561 |
— |
This recall is being issued due to items within the kit have expired prior to the overall kit expiration date listed on the insert. |
| 2023-11-01 |
Class II
|
Ongoing |
Z-0310-2024 |
ADLT BLOOD CULTURE COLLECT KIT, REF DYNDH1245 |
— |
This recall is being issued due to items within the kit have expired prior to the overall kit expiration date listed on the insert. |
| 2023-10-19 |
Class II
|
Ongoing |
Z-0535-2024 |
Medline Leg bag, REF URO12573 |
— |
Undeclared latex |
| 2023-10-19 |
Class II
|
Ongoing |
Z-0534-2024 |
Medline Leg bag, REF DYND12578 |
— |
Undeclared latex |
| 2023-10-19 |
Class II
|
Ongoing |
Z-0533-2024 |
Medline Leg bag, REF DYND12574 |
— |
Undeclared latex |
| 2023-10-16 |
Class I
|
Ongoing |
Z-0563-2024 |
(1) Nurse Kit, SKU #EDUC1025, Case UPC 40195327196647, Non-sterile, For Training Purposes Only, Not For Human Use.; and … |
— |
The component tracheostomy brush has a sharp edge at the tip that can potentially puncture tubing during use and/or cause user injury. Additionally, there have… |
| 2023-10-16 |
Class I
|
Ongoing |
Z-0562-2024 |
(1) Nursing Skills kit, SKU #EDUC05038B, Case UPC 40195327019878, Non-sterile, For Training Purposes Only, Not For Human… |
— |
The component tracheostomy brush has a sharp edge at the tip that can potentially puncture tubing during use and/or cause user injury. Additionally, there have… |
| 2023-10-16 |
Class I
|
Ongoing |
Z-0561-2024 |
Tracheostomy care kits: (1) Medline Tracheostomy Clean and Care Tray with 14 Fr Suction Catheter, REF DYND40580, Ster… |
— |
The component tracheostomy brush has a sharp edge at the tip that can potentially puncture tubing during use and/or cause user injury. Additionally, there have… |
| 2023-08-04 |
Class I
|
Ongoing |
Z-2514-2023 |
HUDSON RCI Addipak, UNIT DOSE VIALS, 5mL Sterile 0.9% NaCl Solution for Inhalation USP. REF RHUD59U |
— |
Product dispositioned for scrap for sterility failure investigation that was inadvertently shipped to customers. |
| 2023-08-03 |
Class II
|
Ongoing |
Z-2595-2023 |
MEDLINE STERILE IRIS SCISSORS CVD/STD, REF DYNJ04049 |
— |
4.5" Iris Scissors, Sterile, Curved (DYNJ04049) are being recalled due to the potential of the tip protector to fall off. The sharp tip of the scissors could co… |
| 2023-08-03 |
Class II
|
Ongoing |
Z-0120-2024 |
MEDLINE ReNewal Harmonic ACE+7 Shears w/ Adv. Hemostasis Use Only w/ GEN11 SW v2018-1 and Lower, REF HARH45R. surgical … |
— |
Various reprocessed Covidien LigaSure and Ethicon Harmonic devices may have an incomplete seal on the packaging tray. |
| 2023-08-03 |
Class II
|
Ongoing |
Z-0119-2024 |
MEDLINE ReNewal Ligasure Sealer/Divider Nano-Coated Compatible with FT10 Generator, REF LF4418CR. electrosurgical inst… |
— |
Various reprocessed Covidien LigaSure and Ethicon Harmonic devices may have an incomplete seal on the packaging tray. |
| 2023-08-03 |
Class II
|
Ongoing |
Z-0118-2024 |
MEDLINE ReNewal Ligasure Maryland Jaw Sealer/Divider Nano-Coated Complatible with FT10 Generator, REF LF1944CR. elec… |
— |
Various reprocessed Covidien LigaSure and Ethicon Harmonic devices may have an incomplete seal on the packaging tray. |
| 2023-08-03 |
Class II
|
Ongoing |
Z-0117-2024 |
MEDLINE ReNewal Ligasure Blunt Tip Sealer/Divider Nano-Coated Compatible with FT10 Generator, REF LF1844CR. electrosur… |
— |
Various reprocessed Covidien LigaSure and Ethicon Harmonic devices may have an incomplete seal on the packaging tray. |
| 2023-07-03 |
Class II
|
Ongoing |
Z-2366-2023 |
Total Hip Kit, REF DYNJ903275S; surgical convenience kit |
— |
The prep solution included in the Total Hip Kit expires prior to the expiration date of the Kit. |
| 2023-05-23 |
Class II
|
Ongoing |
Z-2649-2023 |
Centurion Sterile CirClamp with 1.45cm Bell Reprocessed, Reorder CR3145K, 1 per package, 12 per case. |
— |
The kits incorrectly contain CirClamp subassembly 345CRSAK which results in the kits containing an incorrect bell and base size. |
| 2023-05-18 |
Class II
|
Ongoing |
Z-2205-2023 |
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) TOTAL JOINT, Model Number CDS9… |
— |
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. |
| 2023-05-18 |
Class II
|
Ongoing |
Z-2204-2023 |
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: KIT,SUCTION CATH,14FR W/WATER, Mo… |
— |
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. |
| 2023-05-18 |
Class II
|
Ongoing |
Z-2203-2023 |
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: BREAST BIOPSY TRAY, Model Number … |
— |
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. |
| 2023-05-18 |
Class II
|
Ongoing |
Z-2202-2023 |
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CVC INFANT INSERTION PACK, Mod… |
— |
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. |
| 2023-05-18 |
Class II
|
Ongoing |
Z-2201-2023 |
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: PROBE COVER PACK, Model Number … |
— |
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. |
| 2023-05-18 |
Class II
|
Ongoing |
Z-2200-2023 |
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ARTERIAL LINE START KIT , Mode… |
— |
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. |
| 2023-05-18 |
Class II
|
Ongoing |
Z-2199-2023 |
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) FEMORAL ARTERIAL LINE BUNDLE, … |
— |
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. |
| 2023-05-18 |
Class II
|
Ongoing |
Z-2198-2023 |
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ULTRASOUND PACK, Model Number… |
— |
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. |
| 2023-05-18 |
Class II
|
Ongoing |
Z-2197-2023 |
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: DIALYSIS ACCESSORY PACK W/O CATHE… |
— |
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. |
| 2023-05-18 |
Class II
|
Ongoing |
Z-2196-2023 |
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) VNUS TRAY, Model Number DYNJ44… |
— |
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. |
| 2023-05-18 |
Class II
|
Ongoing |
Z-2195-2023 |
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CATHETERLESS INSERTION KIT, M… |
— |
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. |
| 2023-05-18 |
Class II
|
Ongoing |
Z-2194-2023 |
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) VANTEX CVC BNDL, 3L 7F 16CM W M… |
— |
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. |
| 2023-05-18 |
Class II
|
Ongoing |
Z-2193-2023 |
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) RADIAL ARTERIAL LINE KIT, Mode… |
— |
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. |
| 2023-05-18 |
Class II
|
Ongoing |
Z-2192-2023 |
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: ARTHROSCOPY PACK, Model Number … |
— |
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. |
| 2023-05-18 |
Class II
|
Ongoing |
Z-2191-2023 |
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CRANIOTOMY CDS-1, Model Numb… |
— |
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. |
| 2023-05-18 |
Class II
|
Ongoing |
Z-2190-2023 |
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: CATH LAB PACK, Model Number DYN… |
— |
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. |
| 2023-05-18 |
Class II
|
Ongoing |
Z-2189-2023 |
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) FETAL SURGERY CDS-LF, Model … |
— |
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. |
| 2023-05-18 |
Class II
|
Ongoing |
Z-2188-2023 |
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: CHN OR DAVINCI PROSTATE, Model … |
— |
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. |
| 2023-05-18 |
Class II
|
Ongoing |
Z-2187-2023 |
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) VAD/PICC IV KIT, Model Numbe… |
— |
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. |
| 2023-05-18 |
Class II
|
Ongoing |
Z-2186-2023 |
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) VISCERAL ANGIOGRAM PACK-LF, … |
— |
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. |
| 2023-05-18 |
Class II
|
Ongoing |
Z-2185-2023 |
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: UNIVERSAL DRESSING & PPE KIT, M… |
— |
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. |
| 2023-05-18 |
Class II
|
Ongoing |
Z-2184-2023 |
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) LACERATION TRAY, Model Numbe… |
— |
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. |
| 2023-05-18 |
Class II
|
Ongoing |
Z-2183-2023 |
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) IV SECUREMENT KIT, Model Num… |
— |
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. |
| 2023-05-18 |
Class II
|
Ongoing |
Z-2182-2023 |
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) UNIVERSAL INSERTION TRAY, Mo… |
— |
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. |
| 2023-05-18 |
Class II
|
Ongoing |
Z-2181-2023 |
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) BLOCK SUPPLIES NDL CNTR, Mode… |
— |
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. |
| 2023-05-18 |
Class II
|
Ongoing |
Z-2180-2023 |
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) VEIN KIT, Model Number DYNJ55… |
— |
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. |
| 2023-05-18 |
Class II
|
Ongoing |
Z-2179-2023 |
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) NO-CATH RADIAL ARTERIAL PREMI… |
— |
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. |
| 2023-05-18 |
Class II
|
Ongoing |
Z-2178-2023 |
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: CATH LAB BASIN PACK, Model Number… |
— |
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. |
| 2023-05-18 |
Class II
|
Ongoing |
Z-2177-2023 |
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) BREAST PACK, Model Number DY… |
— |
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. |
| 2023-05-18 |
Class II
|
Ongoing |
Z-2176-2023 |
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CVC PACK, Model Number DYNJ… |
— |
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. |
| 2023-05-18 |
Class II
|
Ongoing |
Z-2175-2023 |
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CATHETER INSERTION KIT CLABS… |
— |
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. |
| 2023-05-18 |
Class II
|
Ongoing |
Z-2174-2023 |
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: PACK ENDO AAA HYBRID CHRG, Model… |
— |
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. |
| 2023-05-18 |
Class II
|
Ongoing |
Z-2173-2023 |
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) FETOSCOPY CDS-LF, Model Numbe… |
— |
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. |
| 2023-05-18 |
Class II
|
Ongoing |
Z-2172-2023 |
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CHP COCHLEAR SUPPLEMENT CDS, … |
— |
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. |
| 2023-05-18 |
Class II
|
Ongoing |
Z-2171-2023 |
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: STERILE SET FOR IMPLANT-LF, Model… |
— |
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. |
| 2023-05-18 |
Class II
|
Ongoing |
Z-2170-2023 |
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) BREAST BIOPSY KIT, Model Numbe… |
— |
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. |
| 2023-05-18 |
Class II
|
Ongoing |
Z-2169-2023 |
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) FETAL SURGERY CDS-LF, Model Nu… |
— |
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. |
| 2023-05-18 |
Class II
|
Ongoing |
Z-2168-2023 |
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) PORT PACK, Model Number DYNJ64… |
— |
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. |
| 2023-05-18 |
Class II
|
Ongoing |
Z-2167-2023 |
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ARTERIAL BUNDLE NO CATHETER, M… |
— |
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. |
| 2023-05-18 |
Class II
|
Ongoing |
Z-2166-2023 |
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) SILVER CROSS OPEN HEART, Model… |
— |
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. |
| 2023-05-18 |
Class II
|
Ongoing |
Z-2165-2023 |
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) EP PACER PACK, Model Number DY… |
— |
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. |
| 2023-05-18 |
Class II
|
Ongoing |
Z-2164-2023 |
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) MHC VASCULAR HYBRID PK-LF, Mod… |
— |
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. |
| 2023-05-18 |
Class II
|
Ongoing |
Z-2163-2023 |
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a. NORTON CHILDRENS CATH LAB-LF,… |
— |
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. |
| 2023-05-18 |
Class II
|
Ongoing |
Z-2162-2023 |
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CATH PACK, Model Number DYNJ83… |
— |
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. |
| 2023-05-18 |
Class II
|
Ongoing |
Z-2161-2023 |
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ANGIOGRAPHY PACK, Model Number… |
— |
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. |
| 2023-05-18 |
Class II
|
Ongoing |
Z-2160-2023 |
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ANGIOGRAPHY DRAPE PACK, Model … |
— |
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. |
| 2023-05-18 |
Class II
|
Ongoing |
Z-2159-2023 |
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ANGIOGRAPHY DRP PK PEDI CATH, … |
— |
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. |
| 2023-05-18 |
Class II
|
Ongoing |
Z-2158-2023 |
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) NERVE BLOCK ACCESSORY PACK, Mo… |
— |
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. |
| 2023-05-18 |
Class II
|
Ongoing |
Z-2157-2023 |
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: PEDIATRIC EP PACK, Model Number D… |
— |
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. |
| 2023-05-18 |
Class II
|
Ongoing |
Z-2156-2023 |
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) BLOCK PACK, Model Number DYNJ8… |
— |
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. |
| 2023-05-18 |
Class II
|
Ongoing |
Z-2155-2023 |
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: ANESTHESIA OH TOTE, Model Number … |
— |
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. |
| 2023-05-18 |
Class II
|
Ongoing |
Z-2154-2023 |
Medline Probe Cover Kits, Model Numbers: DYNJE5900, DYNJE5910, DYNJE5920, DYNJE5930, DYNJE5940, DYNJEX5900. for use dur… |
— |
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. |
| 2023-05-18 |
Class II
|
Ongoing |
Z-2137-2023 |
MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: a) TOTAL JOINT, Model Number CDS985555S; b) TOTAL KNEE, … |
— |
Affected product lots were mislabeled as "STERILE PVP SLN" when they should have been titled "NON-STERILE PVP SOLUTION, STERILE PACKAGING". |
| 2023-05-18 |
Class II
|
Ongoing |
Z-2136-2023 |
MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: a) OCULOPLASTY PACK, Model Number DYNJ64572A; b) EYE PAC… |
— |
Affected product lots were mislabeled as "STERILE PVP SLN" when they should have been titled "NON-STERILE PVP SOLUTION, STERILE PACKAGING". |
| 2023-05-18 |
Class II
|
Ongoing |
Z-2135-2023 |
MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: HYSTERO PACK, Model Number DYNJ61448A |
— |
Affected product lots were mislabeled as "STERILE PVP SLN" when they should have been titled "NON-STERILE PVP SOLUTION, STERILE PACKAGING". |
| 2023-05-18 |
Class II
|
Ongoing |
Z-2134-2023 |
MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: OISC HAND BEAR, Model Number DYNJ902348L |
— |
Affected product lots were mislabeled as "STERILE PVP SLN" when they should have been titled "NON-STERILE PVP SOLUTION, STERILE PACKAGING". |
| 2023-05-18 |
Class II
|
Ongoing |
Z-2133-2023 |
MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: TOTAL KNEE THEDA, Model Number DYNJ908683A |
— |
Affected product lots were mislabeled as "STERILE PVP SLN" when they should have been titled "NON-STERILE PVP SOLUTION, STERILE PACKAGING". |
| 2023-05-18 |
Class II
|
Ongoing |
Z-2132-2023 |
MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: EAR CDS, Model Number CDS980089O |
— |
Affected product lots were mislabeled as "STERILE PVP SLN" when they should have been titled "NON-STERILE PVP SOLUTION, STERILE PACKAGING". |
| 2023-05-18 |
Class II
|
Ongoing |
Z-2131-2023 |
MEDLINE NON-STERILE PVP SOLUTION, STERILE PACKAGING REF DYNDA2232A |
— |
Affected product lots were mislabeled as "STERILE PVP SLN" when they should have been titled "NON-STERILE PVP SOLUTION, STERILE PACKAGING". |
| 2023-05-15 |
Class II
|
Ongoing |
Z-2339-2023 |
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. BREA… |
— |
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. |
| 2023-05-15 |
Class II
|
Ongoing |
Z-2338-2023 |
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ANGI… |
— |
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. |
| 2023-05-15 |
Class II
|
Ongoing |
Z-2337-2023 |
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CATH… |
— |
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. |
| 2023-05-15 |
Class II
|
Ongoing |
Z-2336-2023 |
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. EGG … |
— |
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. |
| 2023-05-15 |
Class II
|
Ongoing |
Z-2335-2023 |
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CUST… |
— |
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. |
| 2023-05-15 |
Class II
|
Ongoing |
Z-2334-2023 |
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. C V … |
— |
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. |
| 2023-05-15 |
Class II
|
Ongoing |
Z-2333-2023 |
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CHN … |
— |
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. |
| 2023-05-15 |
Class II
|
Ongoing |
Z-2332-2023 |
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. FETA… |
— |
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. |
| 2023-05-15 |
Class II
|
Ongoing |
Z-2331-2023 |
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ANGI… |
— |
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. |
| 2023-05-15 |
Class II
|
Ongoing |
Z-2330-2023 |
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. KIT … |
— |
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. |
| 2023-05-15 |
Class II
|
Ongoing |
Z-2329-2023 |
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. PROB… |
— |
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. |
| 2023-05-15 |
Class II
|
Ongoing |
Z-2328-2023 |
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. DR M… |
— |
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. |
| 2023-05-15 |
Class II
|
Ongoing |
Z-2327-2023 |
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. DBD-… |
— |
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. |
| 2023-05-15 |
Class II
|
Ongoing |
Z-2326-2023 |
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. PREM… |
— |
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. |
| 2023-05-15 |
Class II
|
Ongoing |
Z-2325-2023 |
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CVC … |
— |
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. |
| 2023-05-15 |
Class II
|
Ongoing |
Z-2324-2023 |
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CENT… |
— |
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. |
| 2023-05-15 |
Class II
|
Ongoing |
Z-2323-2023 |
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ADUL… |
— |
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. |
| 2023-05-15 |
Class II
|
Ongoing |
Z-2322-2023 |
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. 18GX6"… |
— |
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. |
| 2023-05-15 |
Class II
|
Ongoing |
Z-2321-2023 |
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. PEDIAT… |
— |
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. |
| 2023-05-15 |
Class II
|
Ongoing |
Z-2320-2023 |
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. DR. RO… |
— |
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. |
| 2023-05-15 |
Class II
|
Ongoing |
Z-2319-2023 |
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. 7F, 20… |
— |
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. |
| 2023-05-15 |
Class II
|
Ongoing |
Z-2318-2023 |
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CATH… |
— |
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. |
| 2023-05-15 |
Class II
|
Ongoing |
Z-2317-2023 |
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. (54)… |
— |
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. |
| 2023-05-15 |
Class II
|
Ongoing |
Z-2316-2023 |
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CVC … |
— |
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. |
| 2023-05-15 |
Class II
|
Ongoing |
Z-2315-2023 |
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CENT… |
— |
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. |
| 2023-05-15 |
Class II
|
Ongoing |
Z-2314-2023 |
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. PACK… |
— |
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. |
| 2023-05-15 |
Class II
|
Ongoing |
Z-2313-2023 |
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. DIAL… |
— |
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. |
| 2023-05-15 |
Class II
|
Ongoing |
Z-2312-2023 |
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ABLA… |
— |
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. |
| 2023-05-15 |
Class II
|
Ongoing |
Z-2311-2023 |
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. LIVE… |
— |
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. |
| 2023-05-15 |
Class II
|
Ongoing |
Z-2310-2023 |
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. DBD-… |
— |
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. |
| 2023-05-15 |
Class II
|
Ongoing |
Z-2309-2023 |
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CARO… |
— |
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. |
| 2023-05-15 |
Class II
|
Ongoing |
Z-2308-2023 |
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as STERILE SET FOR IMPLANT-LF… |
— |
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. |
| 2023-05-15 |
Class II
|
Ongoing |
Z-2307-2023 |
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ABLA… |
— |
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. |
| 2023-05-15 |
Class II
|
Ongoing |
Z-2306-2023 |
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. SHY … |
— |
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. |
| 2023-05-15 |
Class II
|
Ongoing |
Z-2305-2023 |
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. A V FI… |
— |
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. |
| 2023-05-15 |
Class II
|
Ongoing |
Z-2304-2023 |
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. 16CM… |
— |
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. |
| 2023-05-15 |
Class II
|
Ongoing |
Z-2303-2023 |
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. VASC… |
— |
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. |
| 2023-05-15 |
Class II
|
Ongoing |
Z-2302-2023 |
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. OPEN H… |
— |
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. |
| 2023-05-15 |
Class II
|
Ongoing |
Z-2301-2023 |
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ELECTR… |
— |
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. |
| 2023-05-15 |
Class II
|
Ongoing |
Z-2300-2023 |
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. AAA PA… |
— |
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. |
| 2023-05-15 |
Class II
|
Ongoing |
Z-2299-2023 |
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. MULTI-… |
— |
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. |
| 2023-05-15 |
Class II
|
Ongoing |
Z-2298-2023 |
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CRMC M… |
— |
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. |
| 2023-05-15 |
Class II
|
Ongoing |
Z-2297-2023 |
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. (13) S… |
— |
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. |
| 2023-05-15 |
Class II
|
Ongoing |
Z-2296-2023 |
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ANGI… |
— |
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. |
| 2023-05-15 |
Class II
|
Ongoing |
Z-2295-2023 |
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ANGI… |
— |
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. |
| 2023-05-15 |
Class II
|
Ongoing |
Z-2294-2023 |
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as PEDIATRIC EP PACK, Model N… |
— |
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. |
| 2023-05-15 |
Class II
|
Ongoing |
Z-2293-2023 |
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a.18G CP… |
— |
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. |
| 2023-05-15 |
Class II
|
Ongoing |
Z-2292-2023 |
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ART L… |
— |
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. |
| 2023-05-15 |
Class II
|
Ongoing |
Z-2291-2023 |
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ANEST… |
— |
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. |
| 2023-05-15 |
Class II
|
Ongoing |
Z-2290-2023 |
Medline Probe Cover Kits containing Turkuaz Ultrasound Gel, Labeled as the following: a. COVER, PROBE, W/GEL AND BAN… |
— |
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. |
| 2023-05-12 |
Class II
|
Ongoing |
Z-2206-2023 |
Medline O.R. Scissors, S/B, Sterile, 5.5, Model #DYND04000 |
— |
The scissors were manufactured without a tip protector resulting in the scissors breaking through the semi-rigid plastic tray compromising sterility. |
| 2023-05-03 |
Class II
|
Ongoing |
Z-1982-2023 |
MEDLINE THERAHONEY GEL, 100% LEPTOSPERMUM SCOPARIUM HONEY, a) REF MNK0005, b) REF MNK0015 wound gel |
— |
Medline issued a recall on TheraHoney Wound Gel due to the manufacturer notifying Medline of a sterilization dose audit failure on the wound gel and not augment… |
| 2023-04-21 |
Class II
|
Ongoing |
Z-1646-2023 |
Procedure packs: (1) Medline Sterile Arthroscopy Pack, REF: DYNJ64242B; (2) Medline Sterile Shoulder Pack, REF: DYNJ… |
— |
The kits were damaged by water. |
| 2023-03-28 |
Class II
|
Ongoing |
Z-2227-2023 |
DYND3000xxP Series - Flexible Laryngeal Mask Airway Packs |
— |
The case and each (i.e. packet) labels for the DYND3000xxP series do not include an expiration date, however, the lubricating jelly (MDS032280) included in the … |
| 2023-03-02 |
Class II
|
Ongoing |
Z-1407-2023 |
Centurion CirClamp with 1.3cm Bell & Insert Reprocessed, Reorder #CR230K, Sterile. |
— |
The CirClamp subassembly found in the kit was the incorrect size. |
| 2022-12-27 |
Class II
|
Ongoing |
Z-1163-2023 |
(1) Medline Sterile Hand Pack, Item DYNJ63380A, 3 kits per case, contains BD Chloraprep Hi-Lite Orange, 26 mL Applicator… |
— |
The convenience trays had improper placement of some of the components that were in the nonsterile portion of the tray, thus, not receiving sterilization. |
| 2022-12-27 |
Class II
|
Ongoing |
Z-1162-2023 |
(1) Medline Sterile Maximum Barrier Pack-LF, Item DYNJ0248546C, 6 kits per case, contains BD Chloraprep Hi-Lite Orange, … |
— |
The convenience trays had improper placement of some of the components that were in the nonsterile portion of the tray, thus, not receiving sterilization. |
| 2022-12-27 |
Class II
|
Ongoing |
Z-1161-2023 |
Medline Sterile Oncology Port Access Tray, Item #DYNDC2239, 20 sterile kits per case, containing Ethicon Biopatch Protec… |
— |
The convenience trays had improper placement of some of the components that were in the nonsterile portion of the tray, thus, not receiving sterilization. |
| 2022-12-23 |
Class II
|
Ongoing |
Z-1015-2023 |
CENTURION MEDICAL PRODUCTS, SILVER ANTIMICROBIAL VAD DRIVE, REF DT18760 |
— |
The kit contained an expired component. |
| 2022-12-22 |
Class II
|
Ongoing |
Z-1047-2023 |
MEDLINE UNITE FOOT & ANKLE DRILL BIT, 1.3MM Solid Core, REF MPN10013 |
— |
The recall is due to observed intra-operative screw failure. When pre-drilled with ¿1.3mm drill bit for ¿2.0mm screws and ¿1.6mm drill bit for ¿2.4mm we have ob… |
| 2022-12-22 |
Class II
|
Ongoing |
Z-1046-2023 |
MEDLINE UNITE FOOT & ANKLE Screw, Polyaxial Locking, Mini T8 (2.0x8mm), REF MMSL2008 |
— |
The recall is due to observed intra-operative screw failure. When pre-drilled with ¿1.3mm drill bit for ¿2.0mm screws and ¿1.6mm drill bit for ¿2.4mm we have ob… |
| 2022-12-22 |
Class II
|
Ongoing |
Z-1045-2023 |
MEDLINE UNITE FOOT & ANKLE Screw, Non-Locking, Mini T8 (2.0x8mm), REF MMSN2008 |
— |
The recall is due to observed intra-operative screw failure. When pre-drilled with ¿1.3mm drill bit for ¿2.0mm screws and ¿1.6mm drill bit for ¿2.4mm we have ob… |
| 2022-12-07 |
Class II
|
Ongoing |
Z-1128-2023 |
Surgical convenience kits labeled as: a) MEDLINE HAND PACK, Reorder Number DYNJ67850; b) MEDLINE SHOULDER SUSPENSI… |
— |
The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are st… |
| 2022-12-07 |
Class II
|
Ongoing |
Z-1127-2023 |
Surgical convenience kits labeled as: CENTURION MEDICAL PRODUCTS CIRCUMCISION TRAY, Reorder Number CIT3345 |
— |
The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are st… |
| 2022-12-07 |
Class II
|
Ongoing |
Z-1126-2023 |
Surgical convenience kits labeled as: CENTURION MEDICAL PRODUCTS IR INSTRUMENT TRAY, Reorder Number SUT10675 |
— |
The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are st… |
| 2022-12-07 |
Class II
|
Ongoing |
Z-1125-2023 |
Surgical convenience kits labeled as: MEDLINE ARM/MINOR DRAPE CSTM, Reorder Number DYNJCD0063 |
— |
The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are st… |
| 2022-12-07 |
Class II
|
Ongoing |
Z-1124-2023 |
Surgical convenience kits labeled as: a) CENTURION MEDICAL PRODUCTS CENTRAL LINE DRESSING CHANGE K, Reorder Number DT… |
— |
The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are st… |
| 2022-12-07 |
Class II
|
Ongoing |
Z-1123-2023 |
Surgical convenience kits labeled as: MEDLINE PREP TRAY, Reorder Number DYNDL1643A |
— |
The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are st… |
| 2022-12-07 |
Class II
|
Ongoing |
Z-1122-2023 |
Surgical convenience kits labeled as: MEDLINE SHOULDER SUSPENSION I-LF, Reorder Number DYNJSHOULDER |
— |
The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are st… |
| 2022-12-07 |
Class II
|
Ongoing |
Z-1121-2023 |
Surgical convenience kits labeled as: MEDLINE LCPH LAB DRAW KIT, Reorder Number DYNDH1641A |
— |
The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are st… |
| 2022-12-07 |
Class II
|
Ongoing |
Z-1120-2023 |
Surgical convenience kits labeled as: a) MEDLINE PERF. ASSOC. CUT DOWN TRAY, Reorder Number BM17BAD; b) MEDLINE AR… |
— |
The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are st… |
| 2022-12-07 |
Class II
|
Ongoing |
Z-1119-2023 |
Surgical convenience kits labeled as: a) CENTURION MEDICAL PRODUCTS CHEST TUBE INSERTION TRAY, Reorder Number CVI2105;… |
— |
The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are st… |
| 2022-12-07 |
Class II
|
Ongoing |
Z-1118-2023 |
Surgical convenience kits labeled as: a) MEDLINE GENERAL UTILITY, Reorder Number DYNDA2524 b) CENTURION MEDICAL PROD… |
— |
The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are st… |
| 2022-12-07 |
Class II
|
Ongoing |
Z-1117-2023 |
Surgical convenience kits labeled as: CENTURION MEDICAL PRODUCTS L & D TRAY, Reorder Number MNS9065 |
— |
The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are st… |
| 2022-12-07 |
Class II
|
Ongoing |
Z-1116-2023 |
Surgical convenience kits labeled as: MEDLINE PLASTICS/PEDS KIT, Reorder Number DYNDA2489 |
— |
The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are st… |
| 2022-12-07 |
Class II
|
Ongoing |
Z-1115-2023 |
Surgical convenience kits labeled as: CENTURION MEDICAL PRODUCTS TRACHEOSTOMY TRAY, Reorder Number TC7470 |
— |
The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are st… |
| 2022-12-07 |
Class II
|
Ongoing |
Z-1114-2023 |
Surgical convenience kits labeled as: MEDLINE BREAST BIOPSY KIT, Reorder Number DYNDA1224B |
— |
The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are st… |
| 2022-12-07 |
Class II
|
Ongoing |
Z-1113-2023 |
Surgical convenience kits labeled as: CENTURION MEDICAL PRODUCTS NEONATAL PICC TRAY, Reorder Number CVI4685 |
— |
The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are st… |
| 2022-12-07 |
Class II
|
Ongoing |
Z-1112-2023 |
Surgical convenience kits labeled as: MEDLINE CABG PACK, Reorder Number DYNDA2827 |
— |
The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are st… |
| 2022-12-07 |
Class II
|
Ongoing |
Z-1111-2023 |
Surgical convenience kits labeled as: MEDLINE PERF. ASSOC. CUT DOWN TRAY, Reorder Number BM17BAD |
— |
The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are st… |
| 2022-12-07 |
Class II
|
Ongoing |
Z-1110-2023 |
Surgical convenience kits labeled as: MEDLINE ANGIO PORT KIT W/HIGH GRADE IN, Reorder Number DYNDC2691 |
— |
The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are st… |
| 2022-12-07 |
Class II
|
Ongoing |
Z-1109-2023 |
Surgical convenience kits labeled as: MEDLINE PAIN TRAY, Reorder Number DYNJRA1122A |
— |
The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are st… |
| 2022-11-18 |
Class II
|
Ongoing |
Z-0930-2023 |
Medline CISION Sterile Blades. Labeled as follows with corresponding Item Number. a. STERILE BLADE NO. 10 CARBON STEEL… |
— |
Potential of the blade puncturing the outer foil layer causing a breach in the sterile packaging. |
| 2022-11-17 |
Class II
|
Ongoing |
Z-1097-2023 |
Sterile Procedural Trays, labeled as the following: a. KNEE ARTHROSCOPY CDS-LF b. ARTHROSCOPY CDS c. ARTHROSCOPY … |
— |
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging. |
| 2022-11-17 |
Class II
|
Ongoing |
Z-1096-2023 |
Sterile Procedural Trays, labeled as the following: a. SPINAL b. SPINE CDS c. TOTAL ORTHO CDS d. TOTAL KNEE CDS e. CD… |
— |
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging. |
| 2022-11-17 |
Class II
|
Ongoing |
Z-1095-2023 |
Sterile Procedural Trays, labeled as the following: a. BASIC EYE PACK-LF b. VITRECTOMY PACK-LF c. EYE PACK-EAST-L… |
— |
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging. |
| 2022-11-17 |
Class II
|
Ongoing |
Z-1094-2023 |
Sterile Procedural Trays, labeled as the following: a. CELEBRATION ROBOTIC CDS b. DAVINCI CDS UCC-LF c. ROBOTICS … |
— |
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging. |
| 2022-11-17 |
Class II
|
Ongoing |
Z-1093-2023 |
Sterile Procedural Trays, labeled as the following: a. GYN ABD CDS b. LAVH PROCEDURE c. TAH CDS d. CUH LITHOTOMY… |
— |
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging. |
| 2022-11-17 |
Class II
|
Ongoing |
Z-1092-2023 |
Sterile Procedural Trays, labeled as the following: a. C-SECTION OR 30 CDS b. C-SECTION CDS c. C-SECTION CDS d. … |
— |
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging. |
| 2022-11-17 |
Class II
|
Ongoing |
Z-1091-2023 |
Sterile Procedural Trays, labeled as the following: a. GYN-URO LAPSCP CDS-LF b. ROBOTIC CDS c. GYN LAPAROSCOPY CD… |
— |
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging. |
| 2022-11-17 |
Class II
|
Ongoing |
Z-1090-2023 |
Sterile Procedural Trays, labeled as the following: a. PELVISCOPY PACK b. D-PELVISCOPY |
— |
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging. |
| 2022-11-17 |
Class II
|
Ongoing |
Z-1089-2023 |
Sterile Procedural Trays, labeled as the following: a. GYN LAPAROTOMY HARPER PACK-LF b. OB GYN LAP PACK-LF c. VAG… |
— |
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging. |
| 2022-11-17 |
Class II
|
Ongoing |
Z-1088-2023 |
Sterile Procedural Trays, labeled as the following: a. AV SHUNT CDS b. ZALE V-P SHUNT CDS c. NEURO CDS-LF d. MAJ… |
— |
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging. |
| 2022-11-17 |
Class II
|
Ongoing |
Z-1087-2023 |
Sterile Procedural Trays, labeled as the following: AMBULATORY MINI PACK |
— |
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging. |
| 2022-11-17 |
Class II
|
Ongoing |
Z-1086-2023 |
Sterile Procedural Trays, labeled as the following: DR MOTT DRAPE PACK |
— |
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging. |
| 2022-11-17 |
Class II
|
Ongoing |
Z-1085-2023 |
Sterile Procedural Trays, labeled as the following: LS MS PACK |
— |
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging. |
| 2022-11-17 |
Class II
|
Ongoing |
Z-1084-2023 |
Sterile Procedural Trays, labeled as the following: MINOR BASIC PACK-LF |
— |
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging. |
| 2022-11-17 |
Class II
|
Ongoing |
Z-1083-2023 |
Sterile Procedural Trays, labeled as the following: a. MAJOR CDS-LF b. BURN PACK-LF c. BURN PACK d. SMALL BURN |
— |
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging. |
| 2022-11-17 |
Class II
|
Ongoing |
Z-1082-2023 |
Sterile Procedural Trays, labeled as the following: IM NAIL |
— |
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging. |
| 2022-11-17 |
Class II
|
Ongoing |
Z-1081-2023 |
Sterile Procedural Trays, labeled as the following: a. WOUND CLOSURE TRAY b. WOUND PACK |
— |
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging. |
| 2022-11-17 |
Class II
|
Ongoing |
Z-1080-2023 |
Sterile Procedural Trays, labeled as the following: a. UNIVERSAL PLASTIC b. KNEE ARTHROSCOPY PACK |
— |
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging. |
| 2022-11-17 |
Class II
|
Ongoing |
Z-1079-2023 |
Sterile Procedural Trays, labeled as the following: a. BASIN SET-UP PACK b. LAP CHOLE CDS c. MAJOR CDS d. UROLOGY MINO… |
— |
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging. |
| 2022-11-17 |
Class II
|
Ongoing |
Z-1078-2023 |
Sterile Procedural Trays, labeled as the following: a. ST. ANNE'S MAJOR BASIN SET UP b. SINGLE BASIN SET c. DOUBLE… |
— |
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging. |
| 2022-11-17 |
Class II
|
Ongoing |
Z-1077-2023 |
Sterile Procedural Trays, labeled as the following: a. BREAST AUGMENTATION b. BREAST REDUCTION CDS c. CUH ABDOMINO… |
— |
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging. |
| 2022-11-17 |
Class II
|
Ongoing |
Z-1077-2023 |
Sterile Procedural Trays, labeled as the following: a. BREAST AUGMENTATION b. BREAST REDUCTION CDS c. CUH ABDOMINO… |
— |
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging. |
| 2022-11-17 |
Class II
|
Ongoing |
Z-1076-2023 |
Sterile Procedural Trays, labeled as the following: a. ENDOSCOPY-LF b. SEPTO/ENDO |
— |
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging. |
| 2022-11-17 |
Class II
|
Ongoing |
Z-1075-2023 |
Sterile Procedural Trays, labeled as the following: GENERAL ENDOSCOPY |
— |
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging. |
| 2022-11-17 |
Class II
|
Ongoing |
Z-1074-2023 |
Sterile Procedural Trays, labeled as the following: a. LAPAROTOMY CDS-LF b. LAPAROSCOPY CDS-LF c. BASIC LAPAROSCOPY CDS… |
— |
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging. |
| 2022-11-17 |
Class II
|
Ongoing |
Z-1073-2023 |
Sterile Procedural Trays, labeled as the following: a. MINOR/BREAST BIOPSY-LF b. BREAST BIOPSY-LF |
— |
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging. |
| 2022-11-17 |
Class II
|
Ongoing |
Z-1072-2023 |
Sterile Procedural Trays, labeled as the following: a. EAR CDS-LF b. SINUS CDS-1 c. ZALE FESS CDS d. ZALE OTOLOGY CDS e… |
— |
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging. |
| 2022-11-17 |
Class II
|
Ongoing |
Z-1071-2023 |
Sterile Procedural Trays, labeled as the following: a. RHINOPLASTY PACK b. OSC OTOLOGY PACK-LF c. RHYZOTOMY |
— |
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging. |
| 2022-11-17 |
Class II
|
Ongoing |
Z-1070-2023 |
Sterile Procedural Trays, labeled as the following: a. ORAL SURGERY PACK-LF b. EXTRACTION PACK c. ORAL SURGERY PACK… |
— |
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging. |
| 2022-11-17 |
Class II
|
Ongoing |
Z-1069-2023 |
Sterile Procedural Trays, labeled as the following: a. BREAST BIOPSY PACK-LF b. BREAST BIOPSY PACK c. LAPAROTOMY PA… |
— |
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging. |
| 2022-11-17 |
Class II
|
Ongoing |
Z-1068-2023 |
Sterile Procedural Trays, labeled as the following: a. PORT/TRACH INSERTION CDS-3 b. RESIDENT DERM SURG PACK c. THR… |
— |
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging. |
| 2022-11-17 |
Class II
|
Ongoing |
Z-1067-2023 |
Sterile Procedural Trays, labeled as the following: a. EP LAB PACEMAKER PACK b. OPEN HEART CDS c. OPEN HEART CDS d. AAA… |
— |
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging. |
| 2022-11-17 |
Class II
|
Ongoing |
Z-1066-2023 |
Sterile Procedural Trays, labeled as the following: a. CARDIAC CATH PACK-LF; b. ANGIOGRAPHY-NS-LF; c. EP BA… |
— |
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging. |
| 2022-11-17 |
Class II
|
Ongoing |
Z-1065-2023 |
FEMORAL ARTERY PACK-LF. Sterile Procedural Tray |
— |
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging. |
| 2022-11-17 |
Class II
|
Ongoing |
Z-1064-2023 |
UNIVERSAL CORE DR RUNNELS PACK. Sterile Procedural Tray |
— |
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging. |
| 2022-11-17 |
Class II
|
Ongoing |
Z-1063-2023 |
Sterile Procedural Tray, labeled as the following: a. PAIN SERVICE PACK-LF; b. LOCAL BASIC |
— |
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging. |
| 2022-11-17 |
Class II
|
Ongoing |
Z-1062-2023 |
LOCAL PACK. Sterile Procedural Tray. |
— |
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging. |
| 2022-11-17 |
Class II
|
Ongoing |
Z-1061-2023 |
TRACH PACK. Sterile Procedural Tray. |
— |
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging. |
| 2022-11-17 |
Class II
|
Ongoing |
Z-1060-2023 |
ANCILLARY PACK-LF. Sterile Procedural Tray. |
— |
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging. |
| 2022-11-17 |
Class II
|
Ongoing |
Z-1035-2023 |
Non-sterile procedural trays labeled as TOTAL KNEE KIT, 1 per case |
— |
Potential for sterile blades, within non-sterile SPT kits containing the blades, to puncture the outer foil layer causing a breach in the sterile packaging. |
| 2022-11-17 |
Class II
|
Ongoing |
Z-1034-2023 |
Non-sterile procedural trays labeled as THEDA CLARK TOTAL KNEE CDS, 1 per case |
— |
Potential for sterile blades, within non-sterile SPT kits containing the blades, to puncture the outer foil layer causing a breach in the sterile packaging. |
| 2022-11-17 |
Class II
|
Ongoing |
Z-1033-2023 |
Non-sterile procedural trays labeled as ORTHO TRAUMA, 1 per case |
— |
Potential for sterile blades, within non-sterile SPT kits containing the blades, to puncture the outer foil layer causing a breach in the sterile packaging. |
| 2022-11-17 |
Class II
|
Ongoing |
Z-1032-2023 |
Non-sterile procedural trays labeled as MAJOR/MINOR, 3 per case |
— |
Potential for sterile blades, within non-sterile SPT kits containing the blades, to puncture the outer foil layer causing a breach in the sterile packaging. |
| 2022-11-17 |
Class II
|
Ongoing |
Z-1031-2023 |
Non-sterile procedural trays labeled as LAPAROTOMY CDS, 2 per case |
— |
Potential for sterile blades, within non-sterile SPT kits containing the blades, to puncture the outer foil layer causing a breach in the sterile packaging. |
| 2022-11-17 |
Class II
|
Ongoing |
Z-1030-2023 |
Non-sterile procedural trays labeled as LAPAROSCOPIC, 2 per case |
— |
Potential for sterile blades, within non-sterile SPT kits containing the blades, to puncture the outer foil layer causing a breach in the sterile packaging. |
| 2022-11-17 |
Class II
|
Ongoing |
Z-1029-2023 |
Non-sterile procedural trays labeled as CRANI, 2 per case |
— |
Potential for sterile blades, within non-sterile SPT kits containing the blades, to puncture the outer foil layer causing a breach in the sterile packaging. |
| 2022-09-30 |
Class II
|
Ongoing |
Z-0167-2023 |
CENTURION MEDICAL PRODUCTS NICU PICC INSERTION BUNDLE W/O, REF CVI4470. Convenience kit used in medical procedures. |
— |
Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal. |
| 2022-09-30 |
Class II
|
Ongoing |
Z-0166-2023 |
MEDLINE CVC BARRIER KIT, REF DYNJ80485. Convenience kit used in medical procedures. |
— |
Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal. |
| 2022-09-30 |
Class II
|
Ongoing |
Z-0165-2023 |
MEDLINE RADIOLOGY PROCEDURE PACK, REF DYNJ67150A. Convenience kit used in medical procedures. |
— |
Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal. |
| 2022-09-30 |
Class II
|
Ongoing |
Z-0164-2023 |
MEDLINE DENTAL PACK, REF DYNJ66983. Convenience kit used in medical procedures. |
— |
Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal. |
| 2022-09-30 |
Class II
|
Ongoing |
Z-0163-2023 |
MEDLINE LINQ TRAY, REF DYNJ65880A. Convenience kit used in medical/surgical procedures. |
— |
Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal. |
| 2022-09-30 |
Class II
|
Ongoing |
Z-0162-2023 |
MEDLINE LITHOTOMY, REF DYNJ50099C. Convenience kit used in medical/surgical procedures. |
— |
Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal. |
| 2022-09-30 |
Class II
|
Ongoing |
Z-0161-2023 |
BAUSCH + LOMB CATARACT PACK, REF VAL001CPMEA. Convenience kit used in surgical procedures. |
— |
Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal. |
| 2022-09-30 |
Class II
|
Ongoing |
Z-0160-2023 |
BAUSCH + LOMB CATARACT TRAY, REF LYN023FACTB. Convenience kit used in surgical procedures. |
— |
Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal. |
| 2022-09-30 |
Class II
|
Ongoing |
Z-0159-2023 |
BAUSCH + LOMB EYE MUSCLE, REF VAL036EMESB. Convenience kit used in surgical procedures. |
— |
Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal. |
| 2022-09-30 |
Class II
|
Ongoing |
Z-0158-2023 |
BAUSCH + LOMB CATARACT PACK, REF VAL009CTSGA. Convenience kit used in surgical procedures. |
— |
Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal. |
| 2022-09-30 |
Class II
|
Ongoing |
Z-0157-2023 |
BAUSCH + LOMB BASIC OPHTHALMIC PACK, REF LYN023BSBLB. Convenience kit used in surgical procedures. |
— |
Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal. |
| 2022-09-30 |
Class II
|
Ongoing |
Z-0156-2023 |
BAUSCH + LOMB PHACO PACK, REF LYN011PHNHD. Convenience kit used in surgical procedures. |
— |
Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal. |
| 2022-09-30 |
Class II
|
Ongoing |
Z-0155-2023 |
BAUSCH + LOMB EYE PACK, REF LYN003EYSPA. Convenience kit used in surgical procedures. |
— |
Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal. |
| 2022-09-09 |
Class II
|
Ongoing |
Z-0124-2023 |
MEDLINE PRE-OP CHG BATHING KIT Reorder #: P164756 |
— |
Adult Blood Culture Collect kit and Pre-Op Changing Bathing Kit contain an incorrect expiration date on a component with the kit. CHG Solution with the Pre-Op C… |
| 2022-09-09 |
Class II
|
Ongoing |
Z-0123-2023 |
MEDLINE 24 BLOOD CLUTURE KIT, Reorder #: DYNDH1632 |
— |
Adult Blood Culture Collect kit and Pre-Op Changing Bathing Kit contain an incorrect expiration date on a component with the kit. CHG Solution with the Pre-Op C… |
| 2022-09-09 |
Class II
|
Ongoing |
Z-0122-2023 |
MEDLINE BLOOD CLUTURE KIT, Reorder #: DYNDH1592 |
— |
Adult Blood Culture Collect kit and Pre-Op Changing Bathing Kit contain an incorrect expiration date on a component with the kit. CHG Solution with the Pre-Op C… |
| 2022-09-09 |
Class II
|
Ongoing |
Z-0121-2023 |
MEDLINE PHERIPHERAL BLOOD CULTURE DRAW, Reorder #: DYNDH1561 |
— |
Adult Blood Culture Collect kit and Pre-Op Changing Bathing Kit contain an incorrect expiration date on a component with the kit. CHG Solution with the Pre-Op C… |
| 2022-09-09 |
Class II
|
Ongoing |
Z-0120-2023 |
MEDLINE ADLT BLOOD CLUTURE COLLECT KIT, Reorder #: DYNDH1245 |
— |
Adult Blood Culture Collect kit and Pre-Op Changing Bathing Kit contain an incorrect expiration date on a component with the kit. CHG Solution with the Pre-Op C… |
| 2022-09-07 |
Class II
|
Terminated |
Z-0106-2023 |
CENTURION SnagFree Chest Tube insertion Tray, Reorder CHT545 |
— |
One lot of chest tube insertion trays, containing a silk suture component that is restricted to 1 cycle of sterilization, was processed though 2 cycles. |
| 2022-09-01 |
Class II
|
Terminated |
Z-0088-2023 |
VENCLOSE, VENCLOSE PROCEDURE PACK, 7VM, REF VC-PPH-67A. Cardiovascular procedure convenience kit. |
— |
Impacted Venclose Procedure Packs contain a 12cm introducer/sheath component, either component #128626 - SET INTRO 7FX12CM FITS 0.018 or component #137339 - SET… |
| 2022-08-03 |
Class II
|
Ongoing |
Z-1857-2022 |
MEDLINE CLEARPRO TRACH T-PIECE CLOSED SUCTION CATHETER, flat peel pouch EA, 10 EA per Inner Carton (IC), 20 EA/2 Inner c… |
— |
Potential for the suction catheter to come apart from the green connector near the thumb valve. The connector is coming apart from the assembled device when pul… |
| 2022-08-03 |
Class II
|
Ongoing |
Z-1856-2022 |
MEDLINE CLEARPRO TRACH DOUBLE SWIVEL CLOSED SUCTION CATHETER, flat peel pouch EA, 10 EA per Inner Carton (IC), 20 EA/2 I… |
— |
Potential for the suction catheter to come apart from the green connector near the thumb valve. The connector is coming apart from the assembled device when pul… |
| 2022-08-03 |
Class II
|
Ongoing |
Z-1855-2022 |
MEDLINE CLEARPRO DOUBLE SWIVEL CLOSED SUCTION CATHETER, flat peel pouch EA, 10 EA per Inner Carton (IC), 20 EA/2 Inner c… |
— |
Potential for the suction catheter to come apart from the green connector near the thumb valve. The connector is coming apart from the assembled device when pul… |
| 2022-06-29 |
Class II
|
Ongoing |
Z-1493-2022 |
MEDLINE MICRO-KILL GERMICIDAL BLEACH WIPES, Model numbers MSC351420AN, MSC351420ANH, MSC351420ANZ, MSC351430A, MSC351430… |
— |
stability failure |
| 2022-05-11 |
Class II
|
Ongoing |
Z-1287-2022 |
Medline Pill Splitters; 1 each/box; 144 boxes/carton |
— |
Product lid (which houses a blade) is coming unhinged from the base, thus exposing the blade. |
| 2022-04-21 |
Class II
|
Ongoing |
Z-1221-2022 |
MEDLINE Polyurethane Foam Bedside Cleaning Kit, REF DYK100FS |
— |
Sporadic reports were received of discoloration on the foam sponge on certain lots of the product, which has been identified as microbial contamination. |
| 2022-04-21 |
Class II
|
Ongoing |
Z-1220-2022 |
MEDLINE Polyurethane Foam Bedside Cleaning Kit, REF DYK215FS |
— |
Sporadic reports were received of discoloration on the foam sponge on certain lots of the product, which has been identified as microbial contamination. |
| 2022-04-21 |
Class II
|
Ongoing |
Z-1219-2022 |
MEDLINE Polyurethane Bedside Cleaning Kit, REF DYK500FSAW |
— |
Sporadic reports were received of discoloration on the foam sponge on certain lots of the product, which has been identified as microbial contamination. |
| 2022-04-21 |
Class II
|
Ongoing |
Z-1218-2022 |
MEDLINE Polyurethane Foam Bedside Cleaning Kit, REF DYK500FS |
— |
Sporadic reports were received of discoloration on the foam sponge on certain lots of the product, which has been identified as microbial contamination. |
| 2022-04-21 |
Class II
|
Ongoing |
Z-1217-2022 |
MEDLINE Polyurethane Foam Enzymatic Cleaning Sponge, REF DYK1000TSE |
— |
Sporadic reports were received of discoloration on the foam sponge on certain lots of the product, which has been identified as microbial contamination. |
| 2022-03-09 |
Class II
|
Completed |
Z-0941-2022 |
Medline Standard PVC Laryngeal Masks, 1 device per pouch, 5 each pouches per box |
— |
The mask cuff may disconnect from the device's breathing tube. |
| 2022-03-08 |
Class II
|
Terminated |
Z-0933-2022 |
Stanbio TDM/Beta-Hydroxybutyrate Linearity Standards, packaged in boxes containing Levels 1-6, 1 x 4 mL each, REF 2450-6… |
— |
The product was stored incorrectly due to improper storage controls which may lead to delayed results. |
| 2022-03-08 |
Class II
|
Terminated |
Z-0932-2022 |
Hydroxybutyrate LiquiColor Tests - includes 3 bottles (1 of each size, 3mL, 8.5mL, and 50mL) |
— |
Product was improperly store which may cause a delay in results. |
| 2022-03-04 |
Class II
|
Terminated |
Z-0898-2022 |
Excelsior Medical 10mL Sterile Field Saline Flush ZR, 0.9% Sodium Chloride Injection, USP, REF EMZ10091280, Sterile, IV … |
— |
Sterility failure of the exterior of the syringe which may impact the device's ability to be laid on a sterile field. |
| 2022-01-25 |
Class II
|
Terminated |
Z-0678-2022 |
meridian bioscience immunocard STAT! Rotavirus test, REF 750030, 30 tests/kit box. The ImmunoCard STAT! Rotavirus Immun… |
— |
The product was incorrectly shipped at room temperature rather than refrigerated. |
| 2021-12-29 |
Class II
|
Ongoing |
Z-0696-2022 |
MEDLINE Micro-Kill Bleach Germicidal Bleach Wipes |
— |
Micro-Kill Bleach Wipes contain out of specification (low) levels of Sodium Hypochlorite. |
| 2021-12-15 |
Class II
|
Ongoing |
Z-0633-2022 |
CURAD REUSABLE GEL HOT/COLD PACK |
— |
The product contains natural rubber latex but the label states that it does not. |
| 2021-12-01 |
Class II
|
Terminated |
Z-0656-2022 |
Michels Transport Medium, 20ML Prefilled Cont |
— |
Product stored incorrectly in temperature controlled setting instead of refrigeration. |
| 2021-12-01 |
Class II
|
Terminated |
Z-0554-2022 |
HARDY DIAGNOSTICS CatScreen, 25dsk/vial |
— |
Product stored incorrectly in temperature controlled setting instead of refrigeration. |
| 2021-12-01 |
Class II
|
Terminated |
Z-0552-2022 |
Premier Rotaclone, Rx only |
— |
Product stored incorrectly in temperature controlled setting instead of refrigeration. |
| 2021-11-30 |
Class II
|
Terminated |
Z-0404-2022 |
Stanbio TDM/B-Hydroxybutyrate Tri-Level Controls, Ref. No. 2460-605 |
— |
Affected product was shipped from the warehouse at room temperature instead of the required refrigerated environment. |
| 2021-10-22 |
Class II
|
Terminated |
Z-1140-2022 |
ABX Pentra Calcium AS CP, Reagent 90 mL, REF A11A01954 |
— |
Product was shipped from a Medline warehouse to a customer at room temperature instead of refrigerated (ice). If affected product is used, the results from thi… |