Cook Incorporated: 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 TS

Hazard

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.

Details from the source

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. Distribution: Domestic distribution nationwide. Foreign distribution worldwide. Quantity: 5,669 US; 5,286 OUS Lot/code info: 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 30-06-2027 14821851 30-06-2027 14821852 30-06-2027 14821853 30-06-2027 14821854 30-06-2027 14821855 30-06-2027 14827347 05-07-2027 14827348 05-07-2027 14827349 05-07-2027 14827350 05-07-2027 14827351 05-07-2027 14827352 05-07-2027 14827353 05-07-2027 14827354 05-07-2027 14827355 05-07-2027 14827356 05-07-20

UPC codes

00827002022614, 00827002019379, 00827002005907, 00827002019386, 00827002006522, 00827002022553, 00827002006171, 00827002006386, 00827002022744, 00827002005877, 00827002005938, 00827002006508, 00827002006027, 00827002012370, 00827002006645, 00827002021631, 00827002023512, 00827002024083

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.