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Cook Incorporated recalls Bentson Wire Guide (20cm Distal Flexibility with Softened Tip), Guidewire; Reference Part Number: TSFB-35-80 (GPN G013
Recalled October 5, 2022 · FDA recall Z-1827-2022 · 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
5571 US, 409 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
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)
Manufacturer(s)
Cook Incorporated
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →