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Cook Incorporated recalls Rosen Curved Wire Guide, Guidewire Reference Part Number/GPN THSCF-35-220-1.5-ROSEN G01623 THSCF-35-80-1.5-ROSEN G017
Recalled October 5, 2022 · FDA recall Z-1842-2022 · 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
5041 US; 298 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
Rosen Curved Wire Guide, Guidewire Reference Part Number/GPN THSCF-35-220-1.5-ROSEN G01623 THSCF-35-80-1.5-ROSEN G01774 THSCF-35-180-1.5-ROSEN G01264 THSCF-35-145-1.5-ROSEN G01261
Manufacturer(s)
Cook Incorporated
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →