Cook Incorporated recalls Roadrunner PC Wire Guide (The Firm), Guidewire Reference Part Number/GPN RPC-35-145 G06979 RPC-35-80 G09534

Recalled October 5, 2022 · FDA recall Z-1841-2022 · 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

363 US; 244 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

Roadrunner PC Wire Guide (The Firm), Guidewire Reference Part Number/GPN RPC-35-145 G06979 RPC-35-80 G09534

Manufacturer(s)

Cook Incorporated

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