Cook Biotech, Inc.: Device Recall

Recall #Z-0834-2025 · 11/22/2024

Class II: Risk

Recall Details

Recall Number: Z-0834-2025
Classification: Class II
Product Type: Device
Recalling Firm: Cook Biotech, Inc.
Status: Ongoing
Date Initiated: 11/22/2024
Location: W Lafayette, IN, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 10 devices

Reason for Recall

Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the products.

Product Description

Cook Medical Biodesign Dural Graft, REF C-DUR-7X10, REF G31091, Sterile

Distribution Pattern

US (domestic) Distribution to states of IN and MI; and OUS (foreign) to Canada and South Korea.

Other Recalls by Cook Biotech, Inc.

Class II: Risk 11/22/2024

Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the products.
Class II: Risk 11/22/2024

Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the products.
Class II: Risk 08/07/2024

Products expire prior to the expiration date printed on the product labeling
Class II: Risk 08/07/2024

Products expire prior to the expiration date printed on the product labeling
Class II: Risk 08/07/2024

Products expire prior to the expiration date printed on the product labeling

View all recalls by Cook Biotech, Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.