Class II
Medical Device Recall: Cook Medical Biodesign Dural Graft, REF C-DUR-7X10, REF G31091, Sterile
Cook Biotech, Inc. · November 22, 2024
Reason for Recall
Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the products.
Distribution
US (domestic) Distribution to states of IN and MI; and OUS (foreign) to Canada and South Korea.
States Affected
IN, MI
Quantity Affected
10 devices
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0834-2025
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.