| 2026-07-14 |
Class II
|
Ongoing |
Z-2949-2026 |
Cardinal Health Presource Kits: 1) BASIC PACK , Catalog Number: SBA73BPGCA; 2) SPINE PACK … |
— |
Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels. |
| 2026-07-14 |
Class II
|
Ongoing |
Z-2948-2026 |
Cardinal Health Presource Kits: 1) KIT, MER NEURO BACK , Catalog Number: PN33NBMYD; 2) KIT,CHP BASIC NEURO … |
— |
Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels. |
| 2026-07-14 |
Class II
|
Ongoing |
Z-2947-2026 |
Cardinal Health Presource Kits: 1) CHI STD NEURO CRANI OPT 2 , Catalog Number: CHIP99NC27; 2) CHI STD NEURO CRANI O… |
— |
Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels. |
| 2026-07-14 |
Class II
|
Ongoing |
Z-2946-2026 |
Cardinal Health Presource Kits: 1) SEPTO RHINO PACK , Catalog Number: SEN73NSKCF; 2) PACK NEURO MINOR CRAN… |
— |
Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels. |
| 2026-07-14 |
Class II
|
Ongoing |
Z-2945-2026 |
Cardinal Health Presource Kits: 1) ENT TRAY , Catalog Number: 24-0726A; 2) KIT,SINUS … |
— |
Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels. |
| 2026-07-14 |
Class II
|
Ongoing |
Z-2944-2026 |
Cardinal Health Presource Kits: 1) NEWNAN SMR PACK, Catalog Number: SEN21SPPMB |
— |
Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels. |
| 2026-07-14 |
Class II
|
Ongoing |
Z-2943-2026 |
Cardinal Health Presource Kits: 1) HARMONIZED SPINE VCH PHC PACK , Catalog Number: SOP30SPBCC |
— |
Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels. |
| 2026-07-14 |
Class II
|
Ongoing |
Z-2942-2026 |
Cardinal Health Presource Kits: 1) FAT GRAFT ADD KIT , Catalog Number: 21-4720B; 2) TRAY FAT GRAFT ADD … |
— |
Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels. |
| 2026-02-27 |
Class II
|
Ongoing |
Z-1768-2026 |
Cardinal Health Monoject Tuberculin Syringe, 1 mL Luer Lock, Catalog Number 1180100777 |
— |
The outer packaging and blister pack labeling identify the product as 1mL Luer Lock Tuberculin Syringe (Product Code 1180100777), however the syringes contained… |
| 2025-12-26 |
Class II
|
Ongoing |
Z-1203-2026 |
Chest Drainage Units and Accessories: Product Code Description 1. 8888571562 Cardinal Health Sentinel Seal CDU 2.… |
— |
The firm is updating the IFU to clarify the intended patient population for the identified chest drainage units and accessories as adults, 18 years and older. W… |
| 2025-11-12 |
Class II
|
Ongoing |
Z-0897-2026 |
ChemoPlus gowns: Product Code Product Description CT5500T ChemoPlus Full Coverage Sleeve, Universal, Medium Blue, Non-… |
— |
Affected gowns have the incorrect expiration date on the product packaging. Product has a shelf-life of three years which is mislabeled on the product packaging… |
| 2025-09-18 |
Class II
|
Ongoing |
Z-0211-2026 |
Salem Sump PVC Tubes: Product Code/Product Name: 1180264408 Salem Sump" PVC Gastroduodenal Tube, 10 Fr/Ch (3.3 mm) x… |
— |
Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force during use. Firm is providing additional guidance for use. Expans… |
| 2025-09-18 |
Class II
|
Ongoing |
Z-0210-2026 |
Salem Sump PVC Tubes: Product Code/Product Name: 266122 Salem Sump" Stomach Tube, Dual Lumen with Anti-Reflux Valve,… |
— |
Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force during use. Firm is providing additional guidance for use. Expans… |
| 2025-09-18 |
Class II
|
Ongoing |
Z-0209-2026 |
Salem Sump PVC Tubes: Product Code/Product Name: 266197 Salem Sump" Anti-Reflux Valve CE Marked 8888266197 Salem … |
— |
Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force during use. Firm is providing additional guidance for use. Expans… |
| 2025-09-18 |
Class II
|
Ongoing |
Z-0208-2026 |
Salem Sump PVC Tubes: Product Code/Product Name: 8888265108 Salem Sump Silicone Dual Lumen Stomach Tube, Radiopaque … |
— |
Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force during use. Firm is providing additional guidance for use. Expans… |
| 2025-09-18 |
Class II
|
Ongoing |
Z-0207-2026 |
Salem Sump PVC Tubes: Product Code/Product Name: 264929 Salem Sump" Stomach Tube, Dual Lumen, 12 Fr/Ch (4.0 mm) 264… |
— |
Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force during use. Firm is providing additional guidance for use. Expans… |
| 2025-09-18 |
Class II
|
Ongoing |
Z-0206-2026 |
Salem Sump PVC Tubes: Product Code/Product Name: 8888264911E ENFit" SALEM SUMP" PVC TUBE 10FR 36IN 8888264929E EN… |
— |
Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force during use. Firm is providing additional guidance for use. Expans… |
| 2025-05-13 |
Class II
|
Completed |
Z-1919-2025 |
Kendall SCD Blended Comfort Sleeves Knee Length Small - For use with Kendall SCD SmartFlow SKU 84021B Kendall S… |
— |
Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause delay in treatment or therapy. |
| 2025-05-13 |
Class II
|
Completed |
Z-1918-2025 |
Kendall SCD Comfort Sleeves Knee Length Small, Pediatric - For use with Kendall SCD SmartFlow, SKU 84021P Kendall … |
— |
Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause delay in treatment or therapy. |
| 2025-05-13 |
Class II
|
Completed |
Z-1917-2025 |
SCD Comfort Knee Length Small, SKU 84021; Kendall SCD Small Comfort sleeves when used with the Kendall SCD Smartflow Con… |
— |
Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause delay in treatment or therapy. |
| 2025-05-02 |
Class II
|
Ongoing |
Z-1875-2025 |
Catalog No. 8888160648; Umbilical Vessel Catheter 5 French triple lumen |
— |
Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates. |
| 2025-05-02 |
Class II
|
Ongoing |
Z-1874-2025 |
Catalog No. 8888160556; Umbilical Vessel Catheter 5 French dual lumen |
— |
Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates. |
| 2025-05-02 |
Class II
|
Ongoing |
Z-1873-2025 |
Catalog No. 8888160341; Umbilical Vessel Catheter 5 French single lumen |
— |
Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates. |
| 2025-05-02 |
Class II
|
Ongoing |
Z-1872-2025 |
Catalog No. 8888160333; Umbilical Vessel Catheter 3.5 French single lumen |
— |
Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates. |
| 2025-05-02 |
Class II
|
Ongoing |
Z-1871-2025 |
Catalog No. 8888160325; Umbilical Vessel Catheter 2.5 French single lumen |
— |
Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates. |
| 2025-05-02 |
Class II
|
Ongoing |
Z-1870-2025 |
Catalog No. 8888160119; Umbilical Vessel Catheter Insertion Tray with 2.5 and 5 French UVCs |
— |
Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates. |
| 2024-11-08 |
Class II
|
Ongoing |
Z-1137-2025 |
Cardinal Health Presource Kits: 1) ACDF PACK, Catalog Number: SNEHBACSCA; 2) ACDF PACK, Catalog Number: SNEHBACSCB |
— |
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits. |
| 2024-11-08 |
Class II
|
Ongoing |
Z-1136-2025 |
Cardinal Health Presource Kits: 1) OPHTHALMOLOGY ENDO DCR XTRS PK, Catalog Number:SEY30EYRVA; 2) OPHTHALMOLOGY ENDO DC… |
— |
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits. |
| 2024-11-08 |
Class II
|
Ongoing |
Z-1135-2025 |
Cardinal Health Presource Kits: 1) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP11; 2) CHI STD SPINE OPTION 1, Catalog… |
— |
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits. |
| 2024-11-08 |
Class II
|
Ongoing |
Z-1134-2025 |
Cardinal Health Presource Kits: 1) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC12; 2) CHI STD NEURO CRANI OPT 1, C… |
— |
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits. |
| 2024-11-08 |
Class II
|
Ongoing |
Z-1133-2025 |
Cardinal Health Presource Kits: 1) KIT,ROBOTIC HYSTERECTOMY, Catalog Number:PB4FRHWFA; 2) KIT,ROBOTIC HYSTERECTOMY, Ca… |
— |
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits. |
| 2024-11-08 |
Class II
|
Ongoing |
Z-1132-2025 |
Cardinal Health Presource Kits: 1) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number:PE29NSFG4; 2) KIT,NASAL SEPTOPLASTY,FA… |
— |
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits. |
| 2024-11-08 |
Class II
|
Ongoing |
Z-1131-2025 |
Cardinal Health Presource Kits: 1) LARYNGOSCOPY PACK, Catalog Number:SRIET0979N; |
— |
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits. |
| 2024-11-08 |
Class II
|
Ongoing |
Z-1130-2025 |
Cardinal Health Presource Kits: 1) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF104; 2) KIT,MAXILLOFACIAL,PRES… |
— |
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits. |
| 2024-11-08 |
Class II
|
Ongoing |
Z-1129-2025 |
Cardinal Health Presource Kits: 1) KIT, CAROTID ENDARTERECTOMY, Catalog Number:PVV20110B; 2) KIT, CAROTID ENDARTERECTO… |
— |
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits. |
| 2024-11-08 |
Class II
|
Ongoing |
Z-1128-2025 |
Cardinal Health Presource Kits: 1) UROLOGY ROBOTIC PACK, Catalog Number:SOT4FRUWFA; 2) UROLOGY ROBOTIC PACK, Catalog N… |
— |
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits. |
| 2024-11-08 |
Class II
|
Ongoing |
Z-1127-2025 |
Cardinal Health Presource Kits: 1) KIT,NEURO LAMI,MD ANDERSON, Catalog Number:PN76LMM14; 2) KIT,NEURO LAMI,MD ANDERSON… |
— |
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits. |
| 2024-11-08 |
Class II
|
Ongoing |
Z-1126-2025 |
Cardinal Health Presource Kits: 1) KIT,DIEP FLAP , Catalog Number:PB23DFCM3; 2) KIT,DIEP FLAP … |
— |
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits. |
| 2024-11-08 |
Class II
|
Ongoing |
Z-0917-2025 |
Cardinal Health Presource Kits: 1) KIT, H N FREE FLAP, Catalog Number: PEHFHNAMHJ; 2) KIT,H N FREE FLAP , Catalog Num… |
— |
Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits. |
| 2024-11-08 |
Class II
|
Ongoing |
Z-0916-2025 |
Cardinal Health Presource Kits: 1) ORTHO PLASTIC MICROVASCULAR PK , Catalog Number: PGVMFFBLY; 2) ORTHO PLASTIC MICROVAS… |
— |
Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits. |
| 2024-11-08 |
Class II
|
Ongoing |
Z-0915-2025 |
Cardinal Health Presource Kits: 1) CRANIOTOMY PACK, Catalog Number: 2NE69CNK12; 2) CHI STD NEURO CRANI OPT 4, Catalog … |
— |
Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits. |
| 2024-11-08 |
Class II
|
Ongoing |
Z-0914-2025 |
Cardinal Health Presource Kits: 1 ) KIT, FETAL SURGERY, Catalog Number PB11FSC10 2 ) KIT, FETAL SURGERY , Catalog Numb… |
— |
Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits. |
| 2024-11-08 |
Class II
|
Ongoing |
Z-0913-2025 |
Cardinal Health Presource Kits: 0 ) DESCRIPTION Catalog Number: CATALOG #; 1 ) KIT, NASAL , Catalog Number: PE23NSME… |
— |
Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits. |
| 2024-11-08 |
Class II
|
Ongoing |
Z-0912-2025 |
Cardinal Health Presource Kits: 1 ) LARYNGOSCOPY PACK, Catalog Number: SEN11LGUH2 ; 2 ) LARYNGOSCOPY PACK, Catalog Num… |
— |
Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits. |
| 2024-11-08 |
Class II
|
Ongoing |
Z-0911-2025 |
Cardinal Health Presource Kits: 1 ) KIT, MAJOR ORAL SURGERY, Catalog Number: PGDHMOWOE; 2 ) ORP DENTAL PACK , Catalog … |
— |
Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits. |
| 2024-11-08 |
Class II
|
Ongoing |
Z-0910-2025 |
Cardinal Health Presource Kits: 1 ) ANEURYSM PACK , Catalog Number: SCVHFAPBM1; 2 ) ANEURYSM PACK , Catalog Number: SC… |
— |
Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits. |
| 2024-11-08 |
Class II
|
Ongoing |
Z-0909-2025 |
Cardinal Health Presource Kits: 1 ) TRIPLE ENDO PACK, Catalog Number: SBAOCTEHH1:; 2 ) TRIPLE ENDO PACK, Catalog Numbe… |
— |
Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits. |
| 2024-11-08 |
Class II
|
Ongoing |
Z-0908-2025 |
Cardinal Health Presource Kits: 1) KIT,PLASTIC FLAP,Catalog Number PGHDOT951; 2) KIT,ORP PLASTIC FLAP,Catalog Number … |
— |
Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits. |
| 2024-11-01 |
Class II
|
Ongoing |
Z-0675-2025 |
Cardinal Health SMS Elastic Cuff Thumbhook Level 3 Isolation Gown, Full-Back, Product Codes AT6588-2XL, AT6588-BD, AT658… |
— |
Isolation Gowns were manufactured with raw materials that may fail the hydrostatic pressure specification and therefore would not comply with AAMI (The Associat… |
| 2024-11-01 |
Class II
|
Ongoing |
Z-0674-2025 |
Convertor Isolation Gown, AAMI Level 3 protection, Product Codes AT6100, AT6100-XL, AT6200, and AT6200-XL |
— |
Isolation Gowns were manufactured with raw materials that may fail the hydrostatic pressure specification and therefore would not comply with AAMI (The Associat… |
| 2024-09-25 |
Class I
|
Ongoing |
Z-0310-2025 |
Monoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap Soft Pack, REF 1188100777 |
— |
Certain lots of listed lots of Cardinal Health Monoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap Soft Pack have demonstrated incompatibility with needl… |
| 2024-07-24 |
Class II
|
Ongoing |
Z-3302-2024 |
(a) CardinalHealth Salem Sump Dual Lumen Stomach Tube with Anti-Reflux Valve, 12 Fr/Ch (4.0 mm) x 48 in. (122 cm), Model… |
— |
The firm received reports of breakage in the Anti-Reflux Valve (ARV) due to improper use. As a result, changes to labeling were made. |
| 2024-07-24 |
Class II
|
Ongoing |
Z-3301-2024 |
(a) CardinalHealth Salem Sump Dual Lumen Stomach Tube, 12 Fr/Ch (4.0 mm) x 48 in. (122 cm), Model #8888264929, Sterile;… |
— |
The firm received reports of breakage in the Anti-Reflux Valve (ARV) due to improper use. As a result, changes to labeling were made. |
| 2024-05-29 |
Class II
|
Ongoing |
Z-2330-2024 |
Presource kits and trays, labeled as: 1) Neurological Tray, Catalog Number SAN29NICCA; 2) Neurological Tray, Catalog … |
— |
Cardinal Health is following the FDA's recommendations regarding the disposition of affected Jiangsu Shenli Medical Production Co. Ltd (Shenli) Syringes in the … |
| 2024-05-29 |
Class II
|
Ongoing |
Z-2329-2024 |
Presource kits and trays, labeled as: 1) Cardiovascular Procedure Kit, Catalog Number SAN29ANCC3; 2) Cardiovascular P… |
— |
Cardinal Health is following the FDA's recommendations regarding the disposition of affected Jiangsu Shenli Medical Production Co. Ltd (Shenli) Syringes in the … |
| 2024-05-29 |
Class II
|
Ongoing |
Z-2328-2024 |
Presource kits and trays, labeled as: 1) Cardiac Catheterization Kit, Catalog Number SAN69CCKRB; 2) Cardiac Cathete… |
— |
Cardinal Health is following the FDA's recommendations regarding the disposition of affected Jiangsu Shenli Medical Production Co. Ltd (Shenli) Syringes in the … |
| 2024-05-29 |
Class II
|
Ongoing |
Z-2327-2024 |
Presource kits and trays, labeled as: 1) ANGIOGRAPHY PACK, Catalog Number SAN13BS605; 2) ANGIOGRAPHY PACK, Catalog Nu… |
— |
Cardinal Health is following the FDA's recommendations regarding the disposition of affected Jiangsu Shenli Medical Production Co. Ltd (Shenli) Syringes in the … |
| 2024-04-17 |
Class II
|
Ongoing |
Z-1835-2024 |
CardinalHealth Curity Flexible Adhesive Bandage X-Large 2 x 3.75 in. (5.1 x 9.5 cm), Model 44102, Sterile, Hypoallergeni… |
— |
Potential contamination of the product with latex adhesive residual. |
| 2024-03-27 |
Class II
|
Ongoing |
Z-1739-2024 |
Jackson-Pratt 3-Spring Reservoir with Silicone Adapters, 400mL, REF SU130-475 |
— |
Cardinal Health is issuing a lot number specific voluntary removal of Jackson-Pratt 3-Spring Reservoir kits due to specific products being shipped to users befo… |
| 2024-03-27 |
Class II
|
Ongoing |
Z-1738-2024 |
Jackson-Pratt Universal Connector PVC Tubing Anti Reflux Transparent Y, REF SU130-4601 |
— |
Cardinal Health is issuing a lot number specific voluntary removal of Jackson-Pratt 3-Spring Reservoir kits due to specific products being shipped to users befo… |
| 2024-03-27 |
Class II
|
Ongoing |
Z-1737-2024 |
Jackson-Pratt 3-Spring Reservoir Kit with PVC Round Drain, 400mL, 15Fr., REF SU130-403D |
— |
Cardinal Health is issuing a lot number specific voluntary removal of Jackson-Pratt 3-Spring Reservoir kits due to specific products being shipped to users befo… |
| 2024-03-27 |
Class II
|
Ongoing |
Z-1736-2024 |
Jackson-Pratt 3-Spring Reservoir Kit with PVC Round Drain, 400mL, 10Fr., REF SU130-402D |
— |
Cardinal Health is issuing a lot number specific voluntary removal of Jackson-Pratt 3-Spring Reservoir kits due to specific products being shipped to users befo… |
| 2024-03-27 |
Class II
|
Ongoing |
Z-1735-2024 |
Jackson-Pratt 3-Spring Reservoir Kit with PVC Round Drain, 400mL, 7Fr., REF SU130-401D |
— |
Cardinal Health is issuing a lot number specific voluntary removal of Jackson-Pratt 3-Spring Reservoir kits due to specific products being shipped to users befo… |
| 2023-12-28 |
Class I
|
Ongoing |
Z-0859-2024 |
Cardinal Health Monoject, 3 mL Purple Enteral Syringe with Enfit Connection Sterile, REF 403SE |
— |
Cardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject sterile Syringe Luer-… |
| 2023-12-28 |
Class I
|
Ongoing |
Z-0858-2024 |
Cardinal Health Monoject, 1 mL Purple Enteral Syringe with Enfit Connection Sterile, REF 401SE |
— |
Cardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject sterile Syringe Luer-… |
| 2023-12-28 |
Class I
|
Ongoing |
Z-0857-2024 |
Cardinal Health Monoject, 60 mL Syringe Luer-Lock Tip Soft Pack, REF 1186000777T |
— |
Cardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject sterile Syringe Luer-… |
| 2023-12-28 |
Class I
|
Ongoing |
Z-0856-2024 |
Cardinal Health Monoject, 35 mL Syringe Luer-Lock Tip Soft Pack, REF 1183500777 |
— |
Cardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject sterile Syringe Luer-… |
| 2023-12-28 |
Class I
|
Ongoing |
Z-0855-2024 |
Cardinal Health Monoject, 20 mL Syringe Luer-Lock Tip Soft Pack, REF 1182000777 |
— |
Cardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject sterile Syringe Luer-… |
| 2023-12-28 |
Class I
|
Ongoing |
Z-0854-2024 |
Cardinal Health Monoject, 12 mL Syringe Luer-Lock Tip Soft Pack, REF 1181200777T |
— |
Cardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject sterile Syringe Luer-… |
| 2023-12-28 |
Class I
|
Ongoing |
Z-0853-2024 |
Cardinal Health Monoject, 6 mL Syringe Luer-Lock Tip Soft Pack, REF 1180600777 |
— |
Cardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject sterile Syringe Luer-… |
| 2023-12-28 |
Class I
|
Ongoing |
Z-0852-2024 |
Cardinal Health Monoject, 3 mL Syringe Luer-Lock Tip Soft Pack, REF 1180300777 |
— |
Cardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject sterile Syringe Luer-… |
| 2023-12-28 |
Class I
|
Ongoing |
Z-0851-2024 |
Cardinal Health Monoject, 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack, REF 1180100777 |
— |
Cardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject sterile Syringe Luer-… |
| 2023-12-28 |
Class I
|
Ongoing |
Z-0850-2024 |
Cardinal Health Monoject, 60mL Enteral Syringe (purple) - For Use with ENFit Connection System, REF 460SE |
— |
The listed lots of Cardinal Health Monoject Enteral Syringes with ENFit (6, 12, 35, 60 mL) have recognition and compatibility issues with certain syringe entera… |
| 2023-12-28 |
Class I
|
Ongoing |
Z-0849-2024 |
Cardinal Health Monoject, 35mL Enteral Syringe (purple) - For Use with ENFit Connection System, REF 435SE |
— |
The listed lots of Cardinal Health Monoject Enteral Syringes with ENFit (6, 12, 35, 60 mL) have recognition and compatibility issues with certain syringe entera… |
| 2023-12-28 |
Class I
|
Ongoing |
Z-0848-2024 |
Cardinal Health Monoject, 12mL Enteral Syringe (purple) For Use with ENFit Connection System, REF 412SE |
— |
The listed lots of Cardinal Health Monoject Enteral Syringes with ENFit (6, 12, 35, 60 mL) have recognition and compatibility issues with certain syringe entera… |
| 2023-12-28 |
Class I
|
Ongoing |
Z-0847-2024 |
Cardinal Health Monoject, 6ML Enteral Syringe (purple) Low Dose (LDT) - For Use with ENFit Connection System, REF 406SE |
— |
The listed lots of Cardinal Health Monoject Enteral Syringes with ENFit (6, 12, 35, 60 mL) have recognition and compatibility issues with certain syringe entera… |
| 2023-12-21 |
Class II
|
Ongoing |
Z-0756-2024 |
Cardinal Health Suction Canister Liner, MEDI-VAC CRD 1000 mL Suction Canister Liner Kit with 6 mm 1.8 m Tube, REF 65651… |
— |
The above-listed lots of Cardinal Health Medi-Vac CRD" Suction Canister Liners 1L may experience loss of suction on low or low intermittent suction settings, du… |
| 2023-12-21 |
Class II
|
Ongoing |
Z-0755-2024 |
Cardinal Health MEDI-VAC CRD Suction Canister Liner, 1000 mL Suction Canister Liner Kit with 5 mm 1.8 m Tube, REF 65651… |
— |
The above-listed lots of Cardinal Health Medi-Vac CRD" Suction Canister Liners 1L may experience loss of suction on low or low intermittent suction settings, du… |
| 2023-12-21 |
Class II
|
Ongoing |
Z-0754-2024 |
CardinalHealth Suction Canister Liner, MEDI-VAC CRD, REF 65651-510 |
— |
The above-listed lots of Cardinal Health Medi-Vac CRD" Suction Canister Liners 1L may experience loss of suction on low or low intermittent suction settings, du… |
| 2023-12-04 |
Class I
|
Ongoing |
Z-1052-2024 |
Dover" 100% SILICONE FOLEY TRAY, NEEDLELESS, 14 FR (4.7 MM), 5 CC, 2000 ML DRAIN BAG, DRAIN SPOUT; Dover" HYDROGEL COATE… |
— |
Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist. |
| 2023-12-04 |
Class I
|
Ongoing |
Z-1051-2024 |
Dover" 100% SILICONE 400ML U/M TEMP SENSE FOLEY TRAY, LL, 18 FR (6.0 MM), 5CC, 2000ML DRAIN BAG, CSD |
— |
Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist. |
| 2023-12-04 |
Class I
|
Ongoing |
Z-1050-2024 |
Dover" 100% SILICONE FOLEY TRAY, LUER LOCK, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG, DRAIN SPOUT; Dover" 100% SILICONE 4… |
— |
Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist. |
| 2023-12-04 |
Class I
|
Ongoing |
Z-1049-2024 |
Dover" IRRIGATION 1200 CC TRAY, 60 CC PISTON SYRINGE, STERILE SALINE, TIP PROTECTOR, ALCOHOL, LIDDED |
— |
Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist. |
| 2023-12-04 |
Class I
|
Ongoing |
Z-1048-2024 |
Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, COUD¿ TIP, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG; Dover" 100% SILICONE 400… |
— |
Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist. |
| 2023-12-04 |
Class I
|
Ongoing |
Z-1047-2024 |
Dover" HYDROGEL COATED LATEX 400 ML U/M FOLEY TRAY, LL, 14 FR (4.7 MM), 5 CC, 2000 ML DRAIN BAG, CSD; Dover" 100% SILIC… |
— |
Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist. |
| 2023-12-04 |
Class I
|
Ongoing |
Z-1046-2024 |
Dover URINE METER ADD-A-FOLEY TRAY, 200 ML, NEEDLE SAMPLING PORT, DRAIN TUBE, PREP TRAY; Dover UNIVERSAL TRAY, 1000 ML B… |
— |
Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist. |
| 2023-12-04 |
Class I
|
Ongoing |
Z-1045-2024 |
Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, NEEDLE PORT, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG; Dover" HYDROGEL COATED… |
— |
Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist. |
| 2023-12-04 |
Class I
|
Ongoing |
Z-1044-2024 |
TRACH KIT W/HYDROGEN & SALI |
— |
Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist. |
| 2023-12-04 |
Class I
|
Ongoing |
Z-1043-2024 |
Argyle" Suction Catheter Tray with Chimney Valve Sterile Saline 18 Fr/Ch (6.0mm); Argyle" Suction Catheter Tray with Chi… |
— |
Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist. |
| 2023-09-20 |
Class I
|
Ongoing |
Z-0150-2024 |
Monoject" 60 mL Syringe Luer-Lock Tip Soft Pack |
— |
Demonstrated recognition and compatibility issues with syringe infusion pumps. |
| 2023-09-20 |
Class I
|
Ongoing |
Z-0149-2024 |
Monoject" 35 mL Syringe Luer-Lock Tip Soft Pack |
— |
Demonstrated recognition and compatibility issues with syringe infusion pumps. |
| 2023-09-20 |
Class I
|
Ongoing |
Z-0148-2024 |
Monoject 20 mL Syringe Luer-Lock Tip Soft Pack |
— |
Demonstrated recognition and compatibility issues with syringe infusion pumps. |
| 2023-09-20 |
Class I
|
Ongoing |
Z-0147-2024 |
Monoject" 12 mL Syringe Luer-Lock Tip Soft Pack |
— |
Demonstrated recognition and compatibility issues with syringe infusion pumps. |
| 2023-09-20 |
Class I
|
Ongoing |
Z-0146-2024 |
Monoject" 6 mL Syringe Luer-Lock Tip Soft Pack |
— |
Demonstrated recognition and compatibility issues with syringe infusion pumps. |
| 2023-09-20 |
Class I
|
Ongoing |
Z-0145-2024 |
Monoject 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack |
— |
Demonstrated recognition and compatibility issues with syringe infusion pumps. |
| 2023-09-13 |
Class II
|
Ongoing |
Z-0112-2024 |
Monoject(TM) 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack, Model Number/Product Code: 1180100777 |
— |
Syringe contains conical tip that is not compatible with certain needleless IV connector(s). |
| 2023-08-16 |
Class II
|
Ongoing |
Z-0092-2024 |
Presource Fistulogram Pack, Cat. SANOCFGHHA, Hartford Hospital, Sterile. |
— |
Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits). |
| 2023-08-16 |
Class II
|
Ongoing |
Z-0091-2024 |
Procedure packs: (1) Presource PBDS Cat. PN33BPCR2, Kit, Back, Sterile; (2) Presource PBDS Cat. POCGANA11, Kit, ARN Ant… |
— |
XXX |
| 2023-08-16 |
Class II
|
Ongoing |
Z-0090-2024 |
Procedure pack: Presource PBDS Cat. PLMHCSBHF, Hermann Hospital MHHS, Kit, C Section B MHHS, Sterile. |
— |
Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits). |
| 2023-08-16 |
Class II
|
Ongoing |
Z-0089-2024 |
Procedure packs: (1) Presource PBDS Cat. PNVMNIB21, Kit, Neuro IMAS, Sterile; (2) Presource PBDS Cat. PN08LAG13, Kit… |
— |
Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits). |
| 2023-08-16 |
Class II
|
Ongoing |
Z-0088-2024 |
Procedure packs: (1) Presource Portacath Pack, Cat. SANV1PIFSB, Medstar Franklin Square Med CE, Sterile; and (2) Pre… |
— |
Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits). |
| 2023-08-16 |
Class II
|
Ongoing |
Z-0087-2024 |
Procedure packs: (1) Presource PBDS, Cat. PGMHSUESR, Southeast Hospital MHHS, Kit, Set Up No Drape, SE, Sterile; (2)… |
— |
Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits). |
| 2023-08-16 |
Class II
|
Ongoing |
Z-0086-2024 |
Procedure packs: (1) Presource PBDS Cat. PG33BTO21, Ohio State Univ Wexner Med Ctr, Kit, Roux UH, Sterile; (2) Pres… |
— |
Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits). |
| 2023-08-16 |
Class II
|
Ongoing |
Z-0085-2024 |
Procedure pack: Presource PBDS, Cat. PEMHEEESR, Southeast Hospital MHHS, Kit, ENT, SE, Sterile. |
— |
Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits). |
| 2023-08-16 |
Class II
|
Ongoing |
Z-0084-2024 |
Procedure packs: (1) Presource PBDS, Cat. PC71EXOU7, Ohio State Univ Wexner Med Ctr, Kit, Extraction Ross, Sterile; … |
— |
Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits). |
| 2023-08-16 |
Class II
|
Ongoing |
Z-0083-2024 |
Procedure packs: (1) Presource Pain Tray, Catalog SBAHFPTAS2, Advanced Surgery Center SAR, Sterile. (2) Presource … |
— |
Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits). |
| 2023-06-16 |
Class II
|
Ongoing |
Z-2147-2023 |
NovaPlus Infant Heel Warmer, Instant Squeeze Activation, Catalog Number V11460-010 |
— |
Cardinal Health has received an increase in burst/leaking complaints from mid-April to May regarding the above listed lot of the Novalplus Infant Heel Warmer wi… |
| 2023-04-06 |
Class II
|
Ongoing |
Z-1690-2023 |
Presource Kit, SMA21LPUHJ GYN Laparoscopy Pack. Convenience kit used for Laparoscopic surgery |
— |
Inadvertently released for distibution without sterility assurance. |
| 2022-12-14 |
Class II
|
Ongoing |
Z-0994-2023 |
Cardinal Health Jackson-Pratt Channel Drain, 32 Fr, REF JP-2292 |
— |
Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of r… |
| 2022-12-14 |
Class II
|
Ongoing |
Z-0993-2023 |
Cardinal Health Jackson-Pratt Channel Drain, 28 Fr, REF JP-2290 |
— |
Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of r… |
| 2022-12-14 |
Class II
|
Ongoing |
Z-0992-2023 |
Cardinal Health Jackson-Pratt Channel Drain, 24 Fr, REF JP-2234 |
— |
Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of r… |
| 2022-12-14 |
Class II
|
Ongoing |
Z-0991-2023 |
Cardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-2233 |
— |
Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of r… |
| 2022-12-14 |
Class II
|
Ongoing |
Z-0990-2023 |
Cardinal Health Jackson-Pratt Channel Drain, 19 Fr, REF JP-2232 |
— |
Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of r… |
| 2022-12-14 |
Class II
|
Ongoing |
Z-0989-2023 |
Cardinal Health Jackson-Pratt Channel Drain, 19 Fr, REF JP-2231 |
— |
Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of r… |
| 2022-12-14 |
Class II
|
Ongoing |
Z-0988-2023 |
Cardinal Health Jackson-Pratt Channel Drain, 19 Fr, REF JP-2230 |
— |
Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of r… |
| 2022-12-14 |
Class II
|
Ongoing |
Z-0987-2023 |
Cardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-2229 |
— |
Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of r… |
| 2022-12-14 |
Class II
|
Ongoing |
Z-0986-2023 |
Cardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-2228 |
— |
Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of r… |
| 2022-12-14 |
Class II
|
Ongoing |
Z-0985-2023 |
Cardinal Health Jackson-Pratt Channel Drain, 10 Fr, REF JP-2227 |
— |
Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of r… |
| 2022-12-14 |
Class II
|
Ongoing |
Z-0984-2023 |
Cardinal Health Jackson-Pratt Channel Drain, 10 Fr, REF JP-2226 |
— |
Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of r… |
| 2022-12-14 |
Class II
|
Ongoing |
Z-0983-2023 |
Cardinal Health Jackson-Pratt Channel Drain, 19 Fr, REF JP-2225 |
— |
Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of r… |
| 2022-12-14 |
Class II
|
Ongoing |
Z-0982-2023 |
Cardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-2223 |
— |
Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of r… |
| 2022-12-14 |
Class II
|
Ongoing |
Z-0981-2023 |
Cardinal Health Jackson-Pratt Channel Drain, 10 Fr, REF JP-2221 |
— |
Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of r… |
| 2022-12-14 |
Class II
|
Ongoing |
Z-0980-2023 |
Cardinal Health Jackson-Pratt Channel Drain, 10 mm, REF JP-2217 |
— |
Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of r… |
| 2022-12-14 |
Class II
|
Ongoing |
Z-0979-2023 |
Cardinal Health Jackson-Pratt Channel Drain, 7 mm, REF JP-2216 |
— |
Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of r… |
| 2022-12-14 |
Class II
|
Ongoing |
Z-0978-2023 |
Cardinal Health Jackson-Pratt Channel Drain, 10 mm, REF JP-2215 |
— |
Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of r… |
| 2022-12-14 |
Class II
|
Ongoing |
Z-0977-2023 |
Cardinal Health Jackson-Pratt Channel Drain, 10 mm, REF JP-2214 |
— |
Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of r… |
| 2022-12-14 |
Class II
|
Ongoing |
Z-0976-2023 |
Cardinal Health Jackson-Pratt Channel Drain, 10 mm, REF JP-2213 |
— |
Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of r… |
| 2022-12-14 |
Class II
|
Ongoing |
Z-0975-2023 |
Cardinal Health Jackson-Pratt Channel Drain, 10 mm, REF JP-2212 |
— |
Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of r… |
| 2022-12-14 |
Class II
|
Ongoing |
Z-0974-2023 |
Cardinal Health Jackson-Pratt Channel Drain, 7 mm, REF JP-2211 |
— |
Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of r… |
| 2022-12-14 |
Class II
|
Ongoing |
Z-0973-2023 |
Cardinal Health Jackson-Pratt Channel Drain, 7 mm, REF JP-2210 |
— |
Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of r… |
| 2022-12-14 |
Class II
|
Ongoing |
Z-0972-2023 |
Cardinal Health Jackson-Pratt Channel Drain, 19 Fr, REF JP-2191 |
— |
Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of r… |
| 2022-12-14 |
Class II
|
Ongoing |
Z-0971-2023 |
Cardinal Health Jackson-Pratt Channel Drain, 19 Fr, REF JP-2190 |
— |
Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of r… |
| 2022-12-14 |
Class II
|
Ongoing |
Z-0970-2023 |
Cardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-2189 |
— |
Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of r… |
| 2022-12-14 |
Class II
|
Ongoing |
Z-0969-2023 |
Cardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-2188 |
— |
Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of r… |
| 2022-12-14 |
Class II
|
Ongoing |
Z-0968-2023 |
Cardinal Health Jackson-Pratt Channel Drain, 10 Fr, REF JP-2187 |
— |
Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of r… |
| 2022-12-14 |
Class II
|
Ongoing |
Z-0967-2023 |
Cardinal Health Jackson-Pratt Channel Drain, 10 Fr, REF JP-2186 |
— |
Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of r… |
| 2022-11-18 |
Class II
|
Ongoing |
Z-1159-2023 |
Cardinal Health Presource Packs IV START KIT-Intended for IV Access CATALOG #: 01A4553E |
— |
Presource Kits contains the ICU MicroClave Clear Connector due to a manufacturing defect there is a gap between the connectors top and bottom housings which m… |
| 2022-11-18 |
Class II
|
Ongoing |
Z-1158-2023 |
Cardinal Health Presource Packs IV START TRAY I-Intended for IV access device CATALOG #: 01-5799A |
— |
Presource Kits contains the ICU MicroClave Clear Connector due to a manufacturing defect there is a gap between the connectors top and bottom housings which m… |
| 2022-11-18 |
Class II
|
Ongoing |
Z-1157-2023 |
Cardinal Health Presource Packs IV START KIT- Intended for IV access device CATALOG #: 01-5798B |
— |
Presource Kits contains the ICU MicroClave Clear Connector due to a manufacturing defect there is a gap between the connectors top and bottom housings which m… |
| 2022-09-28 |
Class II
|
Ongoing |
Z-0192-2023 |
Cardinal Health Reusable Gel Pack, Hot/Cold Pack, 4.5 in. x 10 in., REF 70304A |
— |
Users are being informed that the product should not be used on infants/neonates. A caution statement will be added to the labeling stating: Not for use on In… |
| 2022-09-28 |
Class II
|
Ongoing |
Z-0191-2023 |
Cardinal Health INSULATED GEL PACK REUSABLE, EXTRA LARGE, Cat. 80600 |
— |
Users are being informed that the product should not be used on infants/neonates. A caution statement will be added to the labeling stating: Not for use on In… |
| 2022-09-28 |
Class II
|
Ongoing |
Z-0190-2023 |
Cardinal Health INSULATED GEL PACK REUSABLE, MEDIUM, Cat. 80304A |
— |
Users are being informed that the product should not be used on infants/neonates. A caution statement will be added to the labeling stating: Not for use on In… |
| 2022-09-28 |
Class II
|
Ongoing |
Z-0189-2023 |
Cardinal Health INSULATED GEL PACK REUSABLE, SMALL, Cat. 80204A |
— |
Users are being informed that the product should not be used on infants/neonates. A caution statement will be added to the labeling stating: Not for use on In… |
| 2022-09-28 |
Class II
|
Ongoing |
Z-0188-2023 |
Cardinal Health INSULATED GEL PACK REUSABLE, LARGE, Cat. 80104 |
— |
Users are being informed that the product should not be used on infants/neonates. A caution statement will be added to the labeling stating: Not for use on In… |
| 2022-09-28 |
Class II
|
Ongoing |
Z-0187-2023 |
Cardinal Health HOT AND COLD GEL PACK REUSABLE, M, Cat. 70304 |
— |
Users are being informed that the product should not be used on infants/neonates. A caution statement will be added to the labeling stating: Not for use on In… |
| 2022-09-28 |
Class II
|
Ongoing |
Z-0186-2023 |
Cardinal Health GEL PACK REUSABLE, SMALL, Cat. 70204 |
— |
Users are being informed that the product should not be used on infants/neonates. A caution statement will be added to the labeling stating: Not for use on In… |
| 2022-09-28 |
Class II
|
Ongoing |
Z-0185-2023 |
Cardinal Health GEL PACK REUSABLE, EXTRA SMALL, Cat. 61115 |
— |
Users are being informed that the product should not be used on infants/neonates. A caution statement will be added to the labeling stating: Not for use on In… |
| 2022-03-15 |
Class II
|
Completed |
Z-0902-2022 |
Cardinal Health PROTEXIS PI and PI Classic, Surgical Gloves |
— |
Product was distributed without being sterilized. |
| 2021-06-16 |
Class I
|
Terminated |
Z-2244-2021 |
Argyle UVC Insertion Tray containing Safety Scalpel N11 (vendor part number 73-1811). Intended for use to insert an Umb… |
— |
The current Argyle UVC Insertion Tray does not include a specific IFU to operate the Safety Scalpel N11. The Safety Scalpel N11 features a permanent locking fea… |
| 2021-06-09 |
Class II
|
Terminated |
Z-2095-2021 |
Infant Heel Warmer without Attachment Tab, Nonsterile, Active Product SKU MH00002N The infant heel warmer is activa… |
— |
A caution statement is being added to remind the user to activate away from face and infant as reports of pack rupture or leaking during activation may result… |
| 2021-06-09 |
Class II
|
Terminated |
Z-2094-2021 |
Infant Heel Warmer with Attachment Tab, Nonsterile, Active Product SKU MH00002T The infant heel warmer is activated… |
— |
A caution statement is being added to remind the user to activate away from face and infant as reports of pack rupture or leaking during activation may result… |
| 2021-05-21 |
Class II
|
Terminated |
Z-2038-2021 |
Nonsterile Femoral Angiography Drape, Catalog Numbers: a) 29460NB, b) 29456NB - Product Usage: intended to be used as pr… |
— |
The plastic film used to manufacture these Angiography Drape and Cesarean Birth Drape products is causing the drapes to stick, which may prevent the products fr… |
| 2021-05-21 |
Class II
|
Terminated |
Z-2037-2021 |
Sterile Femoral Angiography Drape, Catalog Numbers: a) 29460, b) 29456 - Product Usage: intended to be used as protecti… |
— |
The plastic film used to manufacture these Angiography Drape and Cesarean Birth Drape products is causing the drapes to stick, which may prevent the products fr… |
| 2021-05-21 |
Class II
|
Terminated |
Z-2036-2021 |
Nonsterile Sterile Cesarean Birth Drape with Dual Layer Anesthesia Screen, Catalog Number 29442N - Product Usage: intend… |
— |
The plastic film used to manufacture these Angiography Drape and Cesarean Birth Drape products is causing the drapes to stick, which may prevent the products fr… |
| 2021-05-21 |
Class II
|
Terminated |
Z-2035-2021 |
Sterile Cesarean Birth Drape with Dual Layer Anesthesia Screen, Catalog Number 29442 - Product Usage: intended to be use… |
— |
The plastic film used to manufacture these Angiography Drape and Cesarean Birth Drape products is causing the drapes to stick, which may prevent the products fr… |
| 2021-05-21 |
Class II
|
Terminated |
Z-2034-2021 |
Nonsterile Radial/Femoral Angiography Drape, Catalog Number 29529N - Product Usage: intended to be used as protective pa… |
— |
The plastic film used to manufacture these Angiography Drape and Cesarean Birth Drape products is causing the drapes to stick, which may prevent the products fr… |
| 2021-05-21 |
Class II
|
Terminated |
Z-2033-2021 |
Sterile Radial/Femoral Angiography Drape, Catalog Number 29529 - Product Usage: intended to be used as protective patien… |
— |
The plastic film used to manufacture these Angiography Drape and Cesarean Birth Drape products is causing the drapes to stick, which may prevent the products fr… |
| 2021-05-21 |
Class II
|
Terminated |
Z-2032-2021 |
Nonsterile Femoral Angiography Drape with Single Pouch, Catalog Number 29525N - Product Usage: intended to be used as pr… |
— |
The plastic film used to manufacture these Angiography Drape and Cesarean Birth Drape products is causing the drapes to stick, which may prevent the products fr… |
| 2021-05-21 |
Class II
|
Terminated |
Z-2031-2021 |
Sterile Femoral Angiography Drape with Single Pouch, Catalog Number 29525 - Product Usage: intended to be used as protec… |
— |
The plastic film used to manufacture these Angiography Drape and Cesarean Birth Drape products is causing the drapes to stick, which may prevent the products fr… |
| 2021-02-25 |
Class II
|
Terminated |
Z-1304-2021 |
Femoral Angiography Drape Bulk Non-Sterile |
— |
Cardinal Health has determined that a manufacturing variance in a plastic film used to manufacture these products is causing the drapes and leggings to stick , … |
| 2021-02-25 |
Class II
|
Terminated |
Z-1303-2021 |
Femoral Angiography Drape Sterile |
— |
Cardinal Health has determined that a manufacturing variance in a plastic film used to manufacture these products is causing the drapes and leggings to stick , … |
| 2021-02-25 |
Class II
|
Terminated |
Z-1302-2021 |
In-View Clear Leggings Bulk Non-Sterile |
— |
Cardinal Health has determined that a manufacturing variance in a plastic film used to manufacture these products is causing the drapes and leggings to stick , … |
| 2021-02-25 |
Class II
|
Terminated |
Z-1301-2021 |
In-View Clear Leggings Sterile Non-Sterile |
— |
Cardinal Health has determined that a manufacturing variance in a plastic film used to manufacture these products is causing the drapes and leggings to stick , … |
| 2021-02-25 |
Class II
|
Terminated |
Z-1300-2021 |
In-View Clear Leggings Sterile |
— |
Cardinal Health has determined that a manufacturing variance in a plastic film used to manufacture these products is causing the drapes and leggings to stick , … |
| 2021-02-11 |
Class II
|
Terminated |
Z-1256-2021 |
JUDKINS PACK |
— |
Component Part Number: 19537LBL (LBL, SHEET OF 39, ASSORTED, STDSZ, MULTI W/BLK INK, WATERPROOF) is being reported as intermittently mixed with an incorrect med… |
| 2021-02-09 |
Class II
|
Terminated |
Z-1252-2021 |
Magellan 3 mL Syringe with Hypodermic Safety Needle, 25 G x 5/8" (0.508 mm x 1.6 cm). A single lumen needle intended to … |
— |
Safety shield not locking into the cannula. If the safety shield activation fails to lock a contaminated needle, a needlestick may occur and there is the potent… |
| 2021-02-09 |
Class II
|
Terminated |
Z-1251-2021 |
McKesson PREVENT M NEEDLE (Magellan Technology) 25G X 5/8". A single lumen needle intended to inject fluids into, or w… |
— |
Safety shield not locking into the cannula. If the safety shield activation fails to lock a contaminated needle, a needlestick may occur and there is the potent… |
| 2021-02-09 |
Class II
|
Terminated |
Z-1250-2021 |
Magellan Hypodermic Safety Needle, 25 G x 5/8" (0.508 mm x 1.6 cm). A single lumen needle intended to inject fluids into… |
— |
Safety shield not locking into the cannula. If the safety shield activation fails to lock a contaminated needle, a needlestick may occur and there is the potent… |
| 2021-01-19 |
Class II
|
Completed |
Z-1347-2021 |
Enteral Infusion Pump |
— |
The potential for air appearing in the enteral feed pumping set tubing during set-up. |
| 2021-01-07 |
Class II
|
Ongoing |
Z-1097-2021 |
Gown Kendall Blue XXL, SKU CT5102 Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provid… |
— |
There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats. |
| 2021-01-07 |
Class II
|
Ongoing |
Z-1096-2021 |
Gown Kendall Blue L, SKU CT5100, CT5101 Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to … |
— |
There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats. |
| 2021-01-07 |
Class II
|
Ongoing |
Z-1095-2021 |
Gown Kendall Blue RG, SKU CT5000 Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide… |
— |
There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats. |
| 2021-01-07 |
Class II
|
Ongoing |
Z-1094-2021 |
Lab Coats SMS 2X-Large White, SKU 2304LC Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to… |
— |
There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats. |
| 2021-01-07 |
Class II
|
Ongoing |
Z-1093-2021 |
Lab Coats SMS Large White, SKU 2302LC Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to pr… |
— |
There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats. |
| 2021-01-07 |
Class II
|
Ongoing |
Z-1092-2021 |
Lab Coats SMS Medium White, SKU 2301LC Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to p… |
— |
There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats. |
| 2021-01-07 |
Class II
|
Ongoing |
Z-1091-2021 |
Lab Coats SMS 2X-Large Blue, SKU 2204LC Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to … |
— |
There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats. |
| 2021-01-07 |
Class II
|
Ongoing |
Z-1090-2021 |
Lab Coats SMS X-Large Blue, SKU 2203LC Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to p… |
— |
There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats. |
| 2021-01-07 |
Class II
|
Ongoing |
Z-1089-2021 |
Lab Coats SMS Large Blue, SKU 2202LC Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to pro… |
— |
There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats. |
| 2021-01-07 |
Class II
|
Ongoing |
Z-1088-2021 |
Gown Isolation W/Ties Xl Blue, SKU 2201PG Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended t… |
— |
There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats. |
| 2021-01-07 |
Class II
|
Ongoing |
Z-1087-2021 |
Gown Isolation W/Ties Univ Blu, SKU 1200PG, 2200PG, 552200PG Cardinal Health Isolation Gown, Lab Coat, and Kendall" G… |
— |
There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats. |
| 2021-01-07 |
Class II
|
Ongoing |
Z-1086-2021 |
Gown Isolation W/Ties Xl Ylw, SKU 1101PG Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to… |
— |
There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats. |
| 2021-01-07 |
Class II
|
Ongoing |
Z-1085-2021 |
Gown Isolation W/Ties Univ Ylw, SKU 1100PG, V1100PG, 2100PG, V2100PG, 2150PG, V2100PG Cardinal Health Isolation Gown,… |
— |
There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats. |
| 2021-01-07 |
Class II
|
Terminated |
Z-1083-2021 |
ChemoPlus" Chemo Prep & Admin Kit, CT4025 |
— |
Gowns included in the kits potentially have rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns. |
| 2021-01-07 |
Class II
|
Terminated |
Z-1082-2021 |
Kendall Spill Kit, 6 Per Case, NonsterileI, BB6016K |
— |
Gowns included in the kits potentially have rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns. |
| 2021-01-07 |
Class II
|
Terminated |
Z-1081-2021 |
ChemoPlus Drug Spill Kit-INSTI, SKU DP5016K |
— |
Gowns included in the kits potentially have rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns. |
| 2021-01-07 |
Class II
|
Terminated |
Z-1080-2021 |
CHEMOPLUS DRUG SPILL KIT HOS, SKU CT4004 |
— |
Gowns included in the kits potentially have rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns. |
| 2021-01-07 |
Class II
|
Terminated |
Z-1079-2021 |
CHEMOBLOC Preparation and Administration Kit, Extra Large Blue Gown, Medium and Large Gloves, Nonsterile, SKU DP5106K |
— |
Gowns included in the kits potentially have rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns. |
| 2021-01-07 |
Class II
|
Terminated |
Z-1078-2021 |
Covidien ChemoPlus Chemo Spill Kit, Nonsterile, SKU DP5108K |
— |
Gowns included in the kits potentially have rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns. |
| 2020-09-25 |
Class II
|
Terminated |
Z-0424-2021 |
Covidien MONOJECT Standard Hypodermic Needle, Polypropylene Hub 22 G x 3/4". Intended use to facilitate activities such … |
— |
Potential for the needle to detach from the cartridge after the bottom of the cartridge is twisted and removed. If the needle is not securely seated, the needle… |
| 2020-09-22 |
Class II
|
Ongoing |
Z-0453-2021 |
Kangaroo Connect 1000ml Bag Set, Non-Sterile, Product Code 77100FD - Product Usage: single-use tubing sets used with pum… |
— |
The feeding spike sets may leak at the interface of the tube and spike connector. |
| 2020-09-22 |
Class II
|
Ongoing |
Z-0452-2021 |
Kangaroo Connect 500ml Bag Set, Non-Sterile, Product Code 77500FD - Product Usage: single-use tubing sets used with pump… |
— |
The feeding spike sets may leak at the interface of the tube and spike connector. |
| 2020-07-30 |
Class II
|
Terminated |
Z-3016-2020 |
KIT, PRE OP DRAH - Product Usage: Preoperative kit used to decolonize intranasal S. aureus. |
— |
Only providing one nasal swab in our pre-operative kit instead of the 4 required for proper treatment. |
| 2020-07-29 |
Class II
|
Completed |
Z-2919-2020 |
PROTEXIS Latex Micro Surgical Gloves Size 9.0 - Product Usage: This surgeon s glove is a disposable device made of natur… |
— |
A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs. |
| 2020-07-29 |
Class II
|
Completed |
Z-2918-2020 |
PROTEXIS Latex Micro Surgical Gloves Size 8.5 - Product Usage: This surgeon s glove is a disposable device made of natur… |
— |
A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs. |
| 2020-07-29 |
Class II
|
Completed |
Z-2917-2020 |
PROTEXIS Latex Micro Surgical Gloves Size 8.0 - Product Usage: This surgeon s glove is a disposable device made of natur… |
— |
A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs. |
| 2020-07-29 |
Class II
|
Completed |
Z-2916-2020 |
PROTEXIS Latex Micro Surgical Gloves Size 7.5 - Product Usage: This surgeon s glove is a disposable device made of natur… |
— |
A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs. |
| 2020-07-29 |
Class II
|
Completed |
Z-2915-2020 |
PROTEXIS Latex Micro Surgical Gloves Size 7.0 - Product Usage: This surgeon s glove is a disposable device made of natur… |
— |
A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs. |
| 2020-07-29 |
Class II
|
Completed |
Z-2914-2020 |
PROTEXIS Latex Micro Surgical Gloves Size 6.5 - Product Usage: This surgeon s glove is a disposable device made of natur… |
— |
A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs. |
| 2020-07-29 |
Class II
|
Completed |
Z-2913-2020 |
PROTEXIS Latex Micro Surgical Gloves Size 6.0 - Product Usage: This surgeon s glove is a disposable device made of natur… |
— |
A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs. |
| 2020-07-29 |
Class II
|
Completed |
Z-2912-2020 |
PROTEXIS Latex Micro Surgical Gloves Size 5.5 - Product Usage: This surgeon s glove is a disposable device made of natur… |
— |
A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs. |
| 2020-06-04 |
Class II
|
Terminated |
Z-2544-2020 |
Cardinal Health NPWT Occlusion Detection Canister 300cc, Prescription Only - Product Usage: The systems are intended for… |
— |
Canisters potentially contain an oversized O-ring that cannot be installed into the mating connector on the device. |
| 2020-06-04 |
Class II
|
Terminated |
Z-2543-2020 |
Cardinal Health NPWT Canister with Gel 300cc, Prescription Only - Product Usage: The systems are intended for use on p… |
— |
Canisters potentially contain an oversized O-ring that cannot be installed into the mating connector on the device. |
| 2020-01-31 |
Class II
|
Terminated |
Z-1301-2020 |
Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1,… |
— |
The kits contained recalled surgical gowns. The gowns were manufactured at locations that did not maintain proper environmental conditions. There is no assuranc… |
| 2020-01-31 |
Class II
|
Terminated |
Z-1235-2020 |
Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1,… |
— |
The kits contained recalled surgical gowns. The gowns were manufactured at locations that did not maintain proper environmental conditions. There is no assura… |
| 2020-01-15 |
Class II
|
Terminated |
Z-1456-2020 |
Monoject Bluntfill with Filter, 18G x 1-1/2" Item Code 11811022F. Used for drawing fluid from a vial - Product Usage: u… |
— |
Non-sterile product was shipped to customers. Product package is labeled as both "STERILE" and "NON-STERILR" ; the product did not undergo sterilization proces… |
| 2020-01-15 |
Class II
|
Terminated |
Z-1455-2020 |
Monoject Hypodermic Safety Needle 25G x 5/8" Item Code 1182558 - Product Usage: used for general purpose injection and … |
— |
Non-sterile product was shipped to customers. Product package is labeled as both "STERILE" and "NON-STERILR" ; the product did not undergo sterilization proces… |
| 2020-01-15 |
Class II
|
Terminated |
Z-1454-2020 |
Monoject Hypodermic Safety Needle 30G X 1/2" Item Code 1183005 - Product Usage: used for general purpose injection and a… |
— |
Non-sterile product was shipped to customers. Product package is labeled as both "STERILE" and "NON-STERILR" ; the product did not undergo sterilization proces… |
| 2020-01-15 |
Class II
|
Terminated |
Z-1453-2020 |
Monoject 3mL Syringe with Hypodermic Safety Needle, 22G x 1-1/2 . Item Code 11832215 - Product Usage: used for general p… |
— |
Non-sterile product was shipped to customers. Product package is labeled as both "STERILE" and "NON-STERILR" ; the product did not undergo sterilization proces… |