BEUDAMED
    FDA Enforcement Class II Ongoing

    Biodesign Fistula Plug C-FPS-0.4-2 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G46372

    Recall: Z-3256-2024 · Reported October 2, 2024

    Enforcement

    Recall Number
    Z-3256-2024
    Event ID
    95149
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Cook Biotech, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 2, 2024
    Initiation Date
    August 7, 2024
    Classification Date
    September 25, 2024
    Address
    1425 Innovation Pl, W Lafayette, IN, 47906-1000, United States

    Description

    Biodesign Fistula Plug C-FPS-0.4-2 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G46372

    Reason

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

    Code Info

    UDI: (01)00827002463721(17)250313(10)LB1524444 (01)00827002463721(17)250313(10)LB1524447 (01)00827002463721(17)250319(10)LB1524448 (01)00827002463721(17)250319(10)LB1524473 (01)00827002463721(17)250416(10)LB1525814 (01)00827002463721(17)250419(10)LB1530195 (01)00827002463721(17)250523(10)LB1534372 (01)00827002463721(17)250702(10)LB1539163 Lot Number: LB1524444 LB1524447 LB1524448 LB1524473 LB1525814 LB1530195 LB1534372 LB1539163

    Distribution

    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.

    Quantity

    39 units