Cook Medical Biodesign Hiatal Hernia Graft, REF C-PHR-7X10-U, REF G31455, Sterile; and
FDA Recall #Z-0833-2025 — Class II — November 22, 2024
Product Description
Cook Medical Biodesign Hiatal Hernia Graft, REF C-PHR-7X10-U, REF G31455, Sterile; and
Reason for Recall
Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the products.
Recalling Firm
Cook Biotech, Inc. — W Lafayette, IN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
6 devices
Distribution
US (domestic) Distribution to states of IN and MI; and OUS (foreign) to Canada and South Korea.
Code Information
Lot #LB1579758, exp. 2/19/2026; Box UDI-DI 10827002314556, Pouch UDI-DI 00827002314559.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated