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Cook Biotech, Inc. recalls Cook Medical Biodesign Hiatal Hernia Graft, REF C-PHR-7X10-U, REF G31455, Sterile; and
Recalled January 22, 2025 · FDA recall Z-0833-2025 · Cook Biotech
Hazard
Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the products. · FDA Class II
Units
6 devices
Sold at
US (domestic) Distribution to states of IN and MI; and OUS (foreign) to Canada and South Korea.
Description
Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the products.
Product
Cook Medical Biodesign Hiatal Hernia Graft, REF C-PHR-7X10-U, REF G31455, Sterile; and
Manufacturer(s)
Cook Biotech, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →