Cook Medical Biodesign Dural Graft, REF C-DUR-7X10, REF G31091, Sterile
FDA Recall #Z-0834-2025 — Class II — November 22, 2024
Product Description
Cook Medical Biodesign Dural Graft, REF C-DUR-7X10, REF G31091, Sterile
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
10 devices
Distribution
US (domestic) Distribution to states of IN and MI; and OUS (foreign) to Canada and South Korea.
Code Information
Lot #LB1581197, exp. 2/4/2026, Box UDI-DI 10827002310916; Pouch UDI-DI 00827002310919.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated