Cook Biotech, Inc.: Device Recall

Recall #Z-3258-2024 · 08/07/2024

Class II: Risk

Recall Details

Recall Number: Z-3258-2024
Classification: Class II
Product Type: Device
Recalling Firm: Cook Biotech, Inc.
Status: Ongoing
Date Initiated: 08/07/2024
Location: W Lafayette, IN, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 3 units

Reason for Recall

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

Product Description

Biodesign Recto-Vaginal Fistula Plug RVP-0.2 - For implantation to reinforce soft tissue for repair of recto-vaginal fistulas. Order Number (GPN): G46601

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of Australia, Austria, Canada, China, Finland, France, Germany, Ireland, Luxembourg, Netherlands, New Zealand, Norway, South Africa, United Kingdom.

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 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

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.