Cook Biotech, Inc. recalls Cook Medical Biodesign Hiatal Hernia Graft, REF C-PHR-7X10-U
Recalled Product
Cook Medical Biodesign Hiatal Hernia Graft, REF C-PHR-7X10-U, REF G31455, Sterile; and
Hazard / Issue
Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the products.
Issued by
FDA
Affected States: IN, MI
Lot/Code Info: Lot #LB1579758, exp. 2/19/2026; Box UDI-DI 10827002314556, Pouch UDI-DI 00827002314559.
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