Cook Incorporated: Bentson Wire Guide (20cm Distal Flexibility with Softened Tip), Guidewire; Reference Part Number: TSFB-35-80 (GPN G01315) TSFB-35-145 (GPN G00691) TSFB-35-200 (GPN G01095)

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: 5571 US, 409 OUS Lot/code info: TSFB-35-80 (GPN G01315) UDI-DI 00827002270411 Lots 14751376 Expiration Date 25-05-2027 TSFB-35-145 (GPN G00691) UDI-DI 00827002006911 Lots Expiration Dates 14813687 27-06-2027 14831302 07-07-2027 14831303 07-07-2027 14831304 07-07-2027 14831305 07-07-2027 14831307 07-07-2027 14831308 07-07-2027 14831309 07-07-2027 14831310 07-07-2027 14831311 07-07-2027 14831313 07-07-2027 14842394 14-07-2027 14842395 14-07-2027 14842396 14-07-2027 14842397 14-07-2027 14842398 14-07-2027 14842399 14-07-2027 14842400 14-07-2027 14842401 14-07-2027 TSFB-35-200 (GPN G01095) UDI-DI 00827002010956 Lot/Expiration Date: 14816668 28-06-2027

UPC codes

00827002270411, 00827002006911, 00827002010956

Source

Official record: FDA (Device enforcement) ↗

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