| 2026-04-02 |
Class I
|
Ongoing |
Z-1936-2026 |
Beacon Tip Centimeter Sizing Catheter RPN/GPN NR5.0-35-70-P-10S-0-CSC-20 G31213 NR5.0-35-100-P-10S-0-CSC-20 G31214 … |
— |
Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include increased procedural time, harms associated with… |
| 2026-04-02 |
Class I
|
Ongoing |
Z-1935-2026 |
Aurous Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20-01 GPN G47308 Sizing catheters are single-use, s… |
— |
Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include increased procedural time, harms associated with… |
| 2026-04-02 |
Class I
|
Ongoing |
Z-1934-2026 |
Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20 GPN G11916 Catheters for use in angiographic procedures… |
— |
Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include increased procedural time, harms associated with… |
| 2026-03-05 |
Class II
|
Ongoing |
Z-1792-2026 |
COOK MEDICAL Wayne Pneumothorax Tray: Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, Order Number G56537; Refer… |
— |
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. |
| 2026-03-05 |
Class II
|
Ongoing |
Z-1791-2026 |
COOK MEDICAL Wayne Pneumothorax Set: Reference Part Number C-UTPT-1020-WAYNE-IMH, Order Number G56532; Reference Part… |
— |
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. |
| 2026-03-05 |
Class II
|
Ongoing |
Z-1790-2026 |
COOK MEDICAL Thal-Quick Chest Tube Tray: Reference Part Number C-TQTSY-3200, Order Number G07242 |
— |
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. |
| 2026-03-05 |
Class II
|
Ongoing |
Z-1789-2026 |
COOK MEDICAL Spectrum¿ Central Venous Tray: Reference Part Number C-UQLMYJ-1001J-RSC-ABRM-HC-FST-A-RD, Order Number G44… |
— |
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. |
| 2026-03-05 |
Class II
|
Ongoing |
Z-1788-2026 |
COOK MEDICAL Spectrum¿ Central Venous Catheter Set: Reference Part Number C-UDLM-401J-ABRM-HC, Order Number G43983; R… |
— |
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. |
| 2026-03-05 |
Class II
|
Ongoing |
Z-1787-2026 |
COOK MEDICAL NCompass¿ Nitinol Stone Extractor: Reference Part Number C-NTSE-2.4-115-NC3, Order Number G36250; Refere… |
— |
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. |
| 2026-03-05 |
Class II
|
Ongoing |
Z-1786-2026 |
COOK MEDICAL Multipurpose Drainage Catheter: Reference Part Number ULT8.5-38-25-P-CLMS-8-RH-FS, Order Number G29775 |
— |
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. |
| 2026-03-05 |
Class II
|
Ongoing |
Z-1785-2026 |
Melker Universal Cuffed Emergency Cricothyrotomy Catheter Set: Reference Part Number C-TCCSB-500-UNI, Order Number G321… |
— |
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. |
| 2026-03-05 |
Class II
|
Ongoing |
Z-1784-2026 |
COOK MEDICAL Cook¿ Strange Bile Duct Stone Exploration Set: Reference Part Number C-CSRC-7.5D-40-STRANGE, Order Number … |
— |
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. |
| 2026-03-05 |
Class II
|
Ongoing |
Z-1783-2026 |
COOK MEDICAL Cook¿ Spectrum¿ Central Venous Catheter Tray: Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0003, Order N… |
— |
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. |
| 2026-03-05 |
Class II
|
Ongoing |
Z-1782-2026 |
COOK MEDICAL Cook Staged Extubation Set: Reference Part Number C-CAE-14.0-83-EXTU, Order Number G24073 |
— |
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. |
| 2026-03-05 |
Class II
|
Ongoing |
Z-1781-2026 |
COOK MEDICAL Ciaglia Blue Rhino Percutaneous Tracheostomy Introducer Set: Reference Part Number C-PTIS-100-FLEX-HC, Ord… |
— |
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. |
| 2026-03-05 |
Class II
|
Ongoing |
Z-1780-2026 |
COOK MEDICAL Blue Rhino¿ G2-Multi Percutaneous Tracheostomy Introducer Tray: Reference Part Number C-PTISY-100-HC-G-NA,… |
— |
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. |
| 2026-03-05 |
Class II
|
Ongoing |
Z-1779-2026 |
COOK MEDICAL Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set: Reference Part Number C-PTIS-100-HC-G-EU, Or… |
— |
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. |
| 2026-03-05 |
Class II
|
Ongoing |
Z-1778-2026 |
COOK MEDICAL Arterial Pressure Monitoring Tray, Reference Part Number APMY-2.5-15-0-2.5 , Order Number G58412; Reference… |
— |
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. |
| 2026-03-05 |
Class II
|
Ongoing |
Z-1777-2026 |
COOK MEDICAL Approach CTO-18 Micro Wire Guide, Reference Part Number CMW-14-190-18G, Order Number G50788; Reference Part… |
— |
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. |
| 2026-03-05 |
Class II
|
Ongoing |
Z-1776-2026 |
COOK MEDICAL Approach CTO-12 Micro Wire Guide: Reference Part Number CMW-14-190-12G, Order Number G50787; Reference Pa… |
— |
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. |
| 2026-03-05 |
Class II
|
Ongoing |
Z-1775-2026 |
COOK MEDICAL Approach CTO-6 Micro Wire Guide, Reference Part Number CMW-14-190-6G, Order Number G50786 |
— |
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. |
| 2025-11-26 |
Class II
|
Ongoing |
Z-0995-2026 |
R¿sch-Uchida Transjugular Liver Access Sets, Reference Part Numbers: RUPS-100; The R¿sch-Uchida Transjugular Liver Ac… |
— |
Cook Medical identified that products supplied in the affected device lots may have been manufactured out of specification. Impacted products may have been cut … |
| 2025-11-26 |
Class II
|
Ongoing |
Z-0994-2026 |
Ring Transjugular Intrahepatic Access Sets, Reference Part Numbers: 1) RTPS-100; 2) RTPS-100-10.0; The Ring Trans… |
— |
Cook Medical identified that products supplied in the affected device lots may have been manufactured out of specification. Impacted products may have been cut … |
| 2025-11-26 |
Class II
|
Ongoing |
Z-0993-2026 |
Flexor Check-Flo Introducers and Sets, Reference Part Numbers: 1) KCFW-9.0-18/38-45-RB-ANL0-HC; 2) KCFW-9.0-18/38-4… |
— |
Cook Medical identified that products supplied in the affected device lots may have been manufactured out of specification. Impacted products may have been cut … |
| 2025-05-15 |
Class I
|
Ongoing |
Z-1902-2025 |
Beacon Tip 5.0 Fr Angiographic catheters are designed to facilitate diagnostic and therapeutic procedures. Catheters are… |
— |
Cook Medical identified that catheters supplied in the affected device lots may experience tip separation. |
| 2025-04-17 |
Class II
|
Ongoing |
Z-1787-2025 |
Check=Flo Performer Introducer, 14.0Fr, Reference Part Number(RPN) REF RCFW-14.0-0-38-30-RB, Order Number (GPN) REF G08… |
— |
Cook Medical identified that devices from the affected device lots may contain the incorrectly sized introducer sheath. |
| 2025-04-17 |
Class II
|
Ongoing |
Z-1786-2025 |
Check=Flo Performer Introducer, 10.0Fr, Reference Part Number(RPN) REF RCFW-10.0-0-38-30-RB, Order Number (GPN) REF G08… |
— |
Cook Medical identified that devices from the affected device lots may contain the incorrectly sized introducer sheath. |
| 2025-04-17 |
Class II
|
Ongoing |
Z-1762-2025 |
Tornado Embolization Microcoil, intended for embolization of selective vessel supply to arteriovenous malformations and … |
— |
Cook Medical identified that devices from the affected device lots may contain the incorrectly sized embolization coil. |
| 2024-10-14 |
Class II
|
Ongoing |
Z-0499-2025 |
Approach CTO Micro Wire Guide, RPN CMW-14-190-25G, GPN G50789 |
— |
Devices from the affected device lots have labels that state the incorrect expiration dates. |
| 2024-10-08 |
Class II
|
Ongoing |
Z-0347-2025 |
Approach Hydro ST Micro Wire Guide; Catalog prefix HMW Reference Part Numbers: HMW-14-135-ST HMW-14-190-ST HMW-14-… |
— |
Affected device lots have labels that state the incorrect expiration dates. |
| 2024-10-08 |
Class II
|
Ongoing |
Z-0346-2025 |
Approach CTO Micro Wire Guide, Guide Wire, Catalog Prefix CMW; Reference Part Numbers: CMW-14-190-12G CMW-14-190-18… |
— |
Affected device lots have labels that state the incorrect expiration dates. |
| 2024-09-16 |
Class II
|
Ongoing |
Z-0045-2025 |
Check-Flo Performer Introducer Set, Reference Part Number RCF-5.0-35-45-J, Order Number G27242. Performer Introducers ar… |
— |
Cook Medical is conducting removal of a lot of Check-Flo Performer Introducer Set due to complaints that the white caps that connect the shaft to the hub of the… |
| 2024-05-15 |
Class II
|
Ongoing |
Z-2223-2024 |
Ultrathane Cook-Cope Type Locking Loop Multipurpose Drainage Catheter-ULT12.0-38-45-P-6S-CLM-RH-ntended for percutaneous… |
— |
Product labels state the incorrect expiration dates that extends beyond their true expiration date |
| 2024-05-15 |
Class II
|
Ongoing |
Z-2222-2024 |
Ultrathane Mac-Loc Locking Loop Multipurpose Drainage Catheter ULT16.0-38-25-P-6S-MCL-HC--Intended for percutaneous drai… |
— |
Product labels state the incorrect expiration dates that extends beyond their true expiration date |
| 2024-03-01 |
Class II
|
Ongoing |
Z-1532-2024 |
Dilator - Coons Taper - Used for dilating puncture sites or catheter tracts for percutaneous placement of devices for va… |
— |
Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility |
| 2024-03-01 |
Class II
|
Ongoing |
Z-1531-2024 |
Dilator With AQ Hydrophilic Coating - Intended to be used for dilating puncture sites or catheter tracts for percutaneou… |
— |
Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility |
| 2024-03-01 |
Class II
|
Ongoing |
Z-1530-2024 |
Dilator - Intended to be used for dilating puncture sites or catheter tracts for percutaneous placement of devices for v… |
— |
Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility |
| 2024-03-01 |
Class II
|
Ongoing |
Z-1529-2024 |
Entuit Secure Adjustable Gastrointestinal Suture Anchor Set - Intended for anchoring the anterior wall of the stomach to… |
— |
Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility |
| 2024-03-01 |
Class II
|
Ongoing |
Z-1528-2024 |
Peel-Away Introducer - Intended for the percutaneous introduction of balloon, electrode and closed or non-tapered end ca… |
— |
Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility |
| 2024-03-01 |
Class II
|
Ongoing |
Z-1527-2024 |
Yueh Centesis Disposable Catheter Needle - Intended for use in percutaneous fluid aspirations, such as paracentesis or t… |
— |
Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility |
| 2024-03-01 |
Class II
|
Ongoing |
Z-1526-2024 |
Trocar Needle - Used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular a… |
— |
Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility |
| 2024-03-01 |
Class II
|
Ongoing |
Z-1525-2024 |
Chiba Biopsy Needle - Used for aspiration biopsy. REFERENCE PART NUMBER (RPN) ORDER NUMBER (GPN): 1) DCHN-18-10.0 … |
— |
Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility |
| 2023-04-07 |
Class I
|
Ongoing |
Z-1428-2023 |
Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Reference Part Numbers C-PTISYJ-100-HC-G-EU-FLEX8.5 (G577… |
— |
There were reports from customers that the tracheostomy in the sets and trays is not making a secure connection with the 15mm cap and other 15mm circuit compone… |
| 2023-04-07 |
Class I
|
Ongoing |
Z-1427-2023 |
Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set, Reference Part Numbers C-PTIS-100-HC-G-EU-FLEX7.5 (G57695)… |
— |
There were reports from customers that the tracheostomy in the sets and trays is not making a secure connection with the 15mm cap and other 15mm circuit compone… |
| 2022-08-16 |
Class II
|
Ongoing |
Z-1847-2022 |
Movable Core Wire Guide (Tefcor), Guidewire (OUS ONLY) Reference Part Number/GPN TMT-35-145 G01677 |
— |
Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of … |
| 2022-08-16 |
Class II
|
Ongoing |
Z-1846-2022 |
Movable Core Wire Guide (Tapered Tefcor) (OUS ONLY), Guidewire Reference Part Number/GPN TCMTNA-35-145-3 G01678 |
— |
Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of … |
| 2022-08-16 |
Class II
|
Ongoing |
Z-1845-2022 |
Lunderquist -Ring Torque Wire Guide, Guidewire Reference Part Number/GPN THSF-35-125-THG G27031 THSF-35-145-THG G2703… |
— |
Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of … |
| 2022-08-16 |
Class II
|
Ongoing |
Z-1844-2022 |
Vinyl Connecting Tube, Connecting Tube Reference Part Number/GPN CTU14.0-30-ST G02278 CTU14.0-40-ST G02327 CTU14.0-3… |
— |
Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of … |
| 2022-08-16 |
Class II
|
Ongoing |
Z-1843-2022 |
Torq-Flex Wire Guide Australian Modification, Guidewire Reference Part Number/GPN STF-18-40-AUST G07304 |
— |
Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of … |
| 2022-08-16 |
Class II
|
Ongoing |
Z-1842-2022 |
Rosen Curved Wire Guide, Guidewire Reference Part Number/GPN THSCF-35-220-1.5-ROSEN G01623 THSCF-35-80-1.5-ROSEN G017… |
— |
Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of … |
| 2022-08-16 |
Class II
|
Ongoing |
Z-1841-2022 |
Roadrunner PC Wire Guide (The Firm), Guidewire Reference Part Number/GPN RPC-35-145 G06979 RPC-35-80 G09534 |
— |
Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of … |
| 2022-08-16 |
Class II
|
Ongoing |
Z-1840-2022 |
Roadrunner PC Wire Guide (The Firm LT), Guidewire Reference Part Number/GPN RLPC-35-145 G06866 |
— |
Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of … |
| 2022-08-16 |
Class II
|
Ongoing |
Z-1839-2022 |
Roadrunner PC Wire Guide (Nimble Floppy), Guidewire RFPC-35-145 G07914 |
— |
Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of … |
| 2022-08-16 |
Class II
|
Ongoing |
Z-1838-2022 |
Roadrunner PC Wire Guide (Nimble), Guidewire Reference Part Number/GPN: RFSPC-35-145 G09607 |
— |
Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of … |
| 2022-08-16 |
Class II
|
Ongoing |
Z-1837-2022 |
Roadrunner PC Hydrophilic Wire Guide, Hydrophilic Guidewire Reference Part Number/GPN: RPC-035145-0-5 G34131 RPC-0351… |
— |
Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of … |
| 2022-08-16 |
Class II
|
Ongoing |
Z-1836-2022 |
Newton Wire Guide (LT Taper/10cm Distal Flexibility), Guidewire Reference Part Number/GPN: TSFNA-35-145 G00701 TSCFNA… |
— |
Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of … |
| 2022-08-16 |
Class II
|
Ongoing |
Z-1835-2022 |
Heavy Double Flexible Tipped Wire Guide, Guidewire Reference Part Number/GPN: THDOC-35-60-0-3 G11949 C-HDOC-18-40-0-2… |
— |
Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of … |
| 2022-08-16 |
Class II
|
Ongoing |
Z-1834-2022 |
Fixed Core Wire Guide (Straight), Guidewire Reference Part Number/GPN: C-SF-18-30 G02261 C-SF-25-40 G01937 TSF-18-26… |
— |
Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of … |
| 2022-08-16 |
Class II
|
Ongoing |
Z-1833-2022 |
Fixed Core Wire Guide (Safe-T-J Curved), Guidewire Reference Part Number/GPN: TSCF-25-180-3 G01602 TSCF-35-180-3 G009… |
— |
Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of … |
| 2022-08-16 |
Class II
|
Ongoing |
Z-1832-2022 |
Fixed Core Wire Guide, Guidewire Reference Part Number/GPN THSCF-25-180-3 G02165 TSCF-25-80-3 G00476 |
— |
Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of … |
| 2022-08-16 |
Class II
|
Ongoing |
Z-1831-2022 |
Double Flexible Tipped Wire Guide, Guidewire Reference Part Number/GPN TDOC-35-145-0-3 G00362 C-TDOC-18-50-0-2 G05146… |
— |
Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of … |
| 2022-08-16 |
Class II
|
Ongoing |
Z-1830-2022 |
Cope Mandril Wire Guide (Stainless Steel), Stainless Steel Guidewire Reference Part Number/GPN PMG-18SP-60-COPE G05183… |
— |
Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of … |
| 2022-08-16 |
Class II
|
Ongoing |
Z-1829-2022 |
Cope Mandril Wire Guide (Nitinol), Nitinol Guidewire; Reference Part Number/GPN: PMG-18SP-60-COPE-NT-ST G09395 PMG-18… |
— |
Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of … |
| 2022-08-16 |
Class II
|
Ongoing |
Z-1828-2022 |
Coons Interventional Wire Guide, Guidewire; Reference Part Number/GPN: THSF-35-145-COONS G02356 THSF-38-145-COONS G02… |
— |
Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of … |
| 2022-08-16 |
Class II
|
Ongoing |
Z-1827-2022 |
Bentson Wire Guide (20cm Distal Flexibility with Softened Tip), Guidewire; Reference Part Number: TSFB-35-80 (GPN G013… |
— |
Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of … |
| 2022-08-16 |
Class II
|
Ongoing |
Z-1826-2022 |
Bentson Wire Guide, Guidewire (OUS ONLY); Reference Part Number: TSMB-35-145 (GPN G27041) |
— |
Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of … |
| 2022-08-16 |
Class II
|
Ongoing |
Z-1825-2022 |
Bentson Plus Wire Guide (Extra Body/20cm Distal Flexibility with Softened Tip), Guidewire; Reference Part Number: TSFB… |
— |
Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of … |
| 2022-08-16 |
Class II
|
Ongoing |
Z-1824-2022 |
Amplatz extra Stiff Wire Guide, Stiff Guidewire (OUS ONLY); Reference Part Number: THSF-35-145-AES-SGH (GPN G06801) T… |
— |
Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of … |
| 2022-07-19 |
Class II
|
Ongoing |
Z-1718-2022 |
Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWS-35-80 ORDER NUMBER (GPN): G56151. F… |
— |
Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may b… |
| 2022-07-19 |
Class II
|
Ongoing |
Z-1717-2022 |
Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWS-35-150 ORDER NUMBER (GPN): G56152. … |
— |
Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may b… |
| 2022-07-19 |
Class II
|
Ongoing |
Z-1716-2022 |
Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWAS-35-80 ORDER NUMBER (GPN): G56175. Fo… |
— |
Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may b… |
| 2022-07-19 |
Class II
|
Ongoing |
Z-1715-2022 |
Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWAS-35-150 ORDER NUMBER (GPN): G56176. F… |
— |
Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may b… |
| 2022-07-19 |
Class II
|
Ongoing |
Z-1714-2022 |
Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWA-35-80 ORDER NUMBER (GPN): G56172. F… |
— |
Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may b… |
| 2022-07-19 |
Class II
|
Ongoing |
Z-1713-2022 |
Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWA-35-150 ORDER NUMBER (GPN): G56173. … |
— |
Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may b… |
| 2022-07-19 |
Class II
|
Ongoing |
Z-1712-2022 |
Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWA-18-80 ORDER NUMBER (GPN): G56162. For… |
— |
Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may b… |
| 2022-07-19 |
Class II
|
Ongoing |
Z-1711-2022 |
Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWA-18-150 ORDER NUMBER (GPN):G56161. For… |
— |
Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may b… |
| 2022-07-19 |
Class II
|
Ongoing |
Z-1710-2022 |
Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPW-35-150 ORDER NUMBER (GPN):G56149. For … |
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Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may b… |
| 2022-07-19 |
Class II
|
Ongoing |
Z-1709-2022 |
Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): RPC-35-180 ORDER NUMBER (GPN):G07518. For vascul… |
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Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may b… |
| 2022-07-19 |
Class II
|
Ongoing |
Z-1708-2022 |
Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN):RLPC-35-180 ORDER NUMBER (GPN) G07516. For vascul… |
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Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may b… |
| 2022-07-19 |
Class II
|
Ongoing |
Z-1707-2022 |
Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): RFSPC-35-180 ORDER NUMBER (GPN) G09608. For vasc… |
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Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may b… |
| 2022-07-19 |
Class II
|
Ongoing |
Z-1706-2022 |
Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN)RFPC-35-180 ORDER NUMBER (GPN) G07937. For vascula… |
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Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may b… |
| 2022-05-25 |
Class II
|
Completed |
Z-1362-2022 |
Pressure Monitoring Set, Single-lumen uncoated central venous catheter. RPN C-PMS-250, GPN G02838 |
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The products may contain excess coating material on the outside and/or interior of the needle component. Potential adverse events that may occur if an affected… |
| 2022-05-05 |
Class II
|
Ongoing |
Z-1242-2022 |
Tornado Embolization Microcoil, RPN GPN MWCE-18S-5/2-TORNADO G08356 MWCE… |
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The loading cartridges included with these devices may contain a small, unintended, stainless-steel cannula. |
| 2022-05-05 |
Class II
|
Ongoing |
Z-1241-2022 |
Nester Embolization Microcoil RPN GPN MWCE-18-5-2-NESTER G52733 MWCE-18-5-3-NE… |
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The loading cartridges included with these devices may contain a small, unintended, stainless-steel cannula. |
| 2022-05-05 |
Class II
|
Ongoing |
Z-1240-2022 |
Hilal Embolization Microcoil, RPN MWCE-18-1.0-0-HILAL-01 (GPN G47499); RPN MWCE-18-0.5-0-HILAL-01 (GPN G47498) |
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The loading cartridges included with these devices may contain a small, unintended, stainless-steel cannula. |