Cook Incorporated recalls Fixed Core Wire Guide (Straight), Guidewire Reference Part Number/GPN: C-SF-18-30 G02261 C-SF-25-40 G01937 TSF-18-26

Recalled October 5, 2022 · FDA recall Z-1834-2022 · Cook Incorporated

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. · FDA Class II

Units

5,669 US; 5,286 OUS

Sold at

Domestic distribution nationwide. Foreign distribution worldwide.

Description

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.

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

Manufacturer(s)

Cook Incorporated

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →