Recall Z-1834-2022
Cook Incorporated · initiated August 16, 2022
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Fixed Core Wire Guide (Straight), Guidewire Reference Part Number/GPN: C-SF-18-30 G02261 C-SF-25-40 G01937 TSF-18-260 G00590 C-SF-25-50 G01938 TSF-35-180 G00652 C-SF-18-40 G02255 TSF-25-145 G00617 TSF-32-145 G00638 C-SF-15-50 G02274 TSF-18-145 G00587 TSF-18-50 G00593 TSF-35-145 G00650 TSF-21-145 G00602 THSF-35-180 G01237 TSF-35-80 G00664 C-SF-25-30 G02163 C-SF-21-30 G02351 THSF-35-80 G02408
Codes / lots: C-SF-18-30 G02261 UDI-DI: 00827002022614 Lot/Expiration Date: 14795056 15-06-2027 C-SF-25-40 G01937 UDI-DI: 00827002019379 Lot/Expiration Date: 14795057 15-06-2027 TSF-18-260 G00590 UDI-DI: 00827002005907 Lot/Expiration date: 14795061 15-06-2027 C-SF-25-50 G01938 UDI-DI: 00827002019386 Lot/Expiration Date: 14795064 15-06-2027 TSF-35-180 G00652 UDI-DI: 00827002006522 Lot/Expiration Date: 14795595 15-06-2027 14795596 15-06-2027 14798673 16-06-2027 14821167 30-06-2027 14822385 30-06-2027 14835601 11-07-2027 C-SF-18-40 G02255 UDI-DI: 00827002022553 Lot/Expiration Date: 14797774 16-06-2027 TSF-25-145 G00617 UDI-DI: 00827002006171 Lot/Expiration Date: 14798256 16-06-2027 14802353 20-06-2027 14821721 30-06-2027 TSF-32-145 G00638 UDI-DI: 00827002006386 Lot/Expiration Date: 14798677 16-06-2027 C-SF-15-50 G02274 UDI-DI: 00827002022744 Lot/Expiration Date: 14802345 20-06-2027 TSF-18-145 G00587 UDI-DI: 00827002005877 Lot/Expiration Date: 14802352 20-06-2027 TSF-18-50 G00593 UDI-DI: 00827002005938 Lot/Expiration Date: 14807597 22-06-2027 TSF-35-145 G00650 UDI-DI: 00827002006508 Lot/Expiration Date: 14809677 23-06-2027 14809679 23-06-2027 14809680 23-06-2027 14821849 30-06-2027 14821850…
Reason for recall
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 affected devices may be compromised.
FDA-determined cause: Under Investigation by firm
Action taken
On August 16, 2022, Cook Medical notified affected customers of the recall. Customers were instructed to immediately cease all further distribution and use of the affected products. Affected product should be quarantined and returned to Cook Medical to receive product credit. If you have any questions or concerns, please contact Cook Medical Customer Relations at 800.457.4500 or 812.339.2235
Details
- Recall number
- Z-1834-2022
- Initiated
- August 16, 2022
- Posted by FDA
- September 28, 2022
- Product code
- DQX – Wire, Guide, Catheter
- Quantity
- 5,669 US; 5,286 OUS
- Distribution
- Domestic distribution nationwide. Foreign distribution worldwide.
- Recalling firm
- Cook Incorporated, Bloomington, IN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1824-2022 Class II | Amplatz extra Stiff Wire Guide, Stiff Guidewire (OUS ONLY); Reference Part Number:…Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron… | 08/16/2022Open, Classified |
| Z-1825-2022 Class II | Bentson Plus Wire Guide (Extra Body/20cm Distal Flexibility with Softened Tip)…Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron… | 08/16/2022Open, Classified |
| Z-1826-2022 Class II | 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… | 08/16/2022Open, Classified |
| Z-1827-2022 Class II | Bentson Wire Guide (20cm Distal Flexibility with Softened Tip), Guidewire; Reference…Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron… | 08/16/2022Open, Classified |
| Z-1828-2022 Class II | Coons Interventional Wire Guide, Guidewire; Reference Part Number/GPN: THSF-35-145-COONS…Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron… | 08/16/2022Open, Classified |
| Z-1829-2022 Class II | Cope Mandril Wire Guide (Nitinol), Nitinol Guidewire; Reference Part Number/GPN:…Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron… | 08/16/2022Open, Classified |
| Z-1830-2022 Class II | Cope Mandril Wire Guide (Stainless Steel), Stainless Steel Guidewire Reference Part…Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron… | 08/16/2022Open, Classified |
| Z-1831-2022 Class II | Double Flexible Tipped Wire Guide, Guidewire Reference Part Number/GPN TDOC-35-145-0-3…Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron… | 08/16/2022Open, Classified |
| Z-1832-2022 Class II | Fixed Core Wire Guide, Guidewire Reference Part Number/GPN THSCF-25-180-3 G02165…Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron… | 08/16/2022Open, Classified |
| Z-1833-2022 Class II | Fixed Core Wire Guide (Safe-T-J Curved), Guidewire Reference Part Number/GPN:…Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron… | 08/16/2022Open, Classified |
| Z-1835-2022 Class II | Heavy Double Flexible Tipped Wire Guide, Guidewire Reference Part Number/GPN:…Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron… | 08/16/2022Open, Classified |
| Z-1836-2022 Class II | Newton Wire Guide (LT Taper/10cm Distal Flexibility), Guidewire Reference Part…Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron… | 08/16/2022Open, Classified |
| Z-1837-2022 Class II | Roadrunner PC Hydrophilic Wire Guide, Hydrophilic Guidewire Reference Part Number/GPN:…Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron… | 08/16/2022Open, Classified |
| Z-1838-2022 Class II | Roadrunner PC Wire Guide (Nimble), Guidewire Reference Part Number/GPN: RFSPC-35-145…Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron… | 08/16/2022Open, Classified |
| Z-1839-2022 Class II | Roadrunner PC Wire Guide (Nimble Floppy), Guidewire RFPC-35-145 G07914Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron… | 08/16/2022Open, Classified |
| Z-1840-2022 Class II | Roadrunner PC Wire Guide (The Firm LT), Guidewire Reference Part Number/GPN RLPC-35-145…Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron… | 08/16/2022Open, Classified |
| Z-1841-2022 Class II | Roadrunner PC Wire Guide (The Firm), Guidewire Reference Part Number/GPN RPC-35-145…Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron… | 08/16/2022Open, Classified |
| Z-1842-2022 Class II | Rosen Curved Wire Guide, Guidewire Reference Part Number/GPN THSCF-35-220-1.5-ROSEN…Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron… | 08/16/2022Open, Classified |
| Z-1843-2022 Class II | Torq-Flex Wire Guide Australian Modification, Guidewire Reference Part Number/GPN…Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron… | 08/16/2022Open, Classified |
| Z-1844-2022 Class II | Vinyl Connecting Tube, Connecting Tube Reference Part Number/GPN CTU14.0-30-ST G02278…Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron… | 08/16/2022Open, Classified |
| Z-1845-2022 Class II | Lunderquist -Ring Torque Wire Guide, Guidewire Reference Part Number/GPN THSF-35-125-THG…Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron… | 08/16/2022Open, Classified |
| Z-1846-2022 Class II | Movable Core Wire Guide (Tapered Tefcor) (OUS ONLY), Guidewire Reference Part Number/GPN…Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron… | 08/16/2022Open, Classified |
| Z-1847-2022 Class II | Movable Core Wire Guide (Tefcor), Guidewire (OUS ONLY) Reference Part Number/GPN…Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron… | 08/16/2022Open, Classified |