BEUDAMED
    FDA Enforcement Class II Ongoing

    Cook Medical Biodesign Hiatal Hernia Graft, REF C-PHR-7X10-U, REF G31455, Sterile; and

    Recall: Z-0833-2025 · Reported January 22, 2025

    Enforcement

    Recall Number
    Z-0833-2025
    Event ID
    95961
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Cook Biotech, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    January 22, 2025
    Initiation Date
    November 22, 2024
    Classification Date
    January 10, 2025
    Address
    1425 Innovation Pl, W Lafayette, IN, 47906-1000, United States

    Description

    Cook Medical Biodesign Hiatal Hernia Graft, REF C-PHR-7X10-U, REF G31455, Sterile; and

    Reason

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

    Code Info

    Lot #LB1579758, exp. 2/19/2026; Box UDI-DI 10827002314556, Pouch UDI-DI 00827002314559.

    Distribution

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

    Quantity

    6 devices