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Cook Incorporated recalls Movable Core Wire Guide (Tapered Tefcor) (OUS ONLY), Guidewire Reference Part Number/GPN TCMTNA-35-145-3 G01678
Recalled October 5, 2022 · FDA recall Z-1846-2022 · 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
No distribution (Distribution Center only)
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
Movable Core Wire Guide (Tapered Tefcor) (OUS ONLY), Guidewire Reference Part Number/GPN TCMTNA-35-145-3 G01678
Manufacturer(s)
Cook Incorporated
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →