BEUDAMED
    FDA Enforcement Class II Ongoing

    Biodesign Fistula Plug C-FPS-0.4 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G54613

    Recall: Z-3253-2024 · Reported October 2, 2024

    Enforcement

    Recall Number
    Z-3253-2024
    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 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G54613

    Reason

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

    Code Info

    UDI: (01)00827002546134(17) Lot Number: LB1524439 LB1524440 LB1524442 LB1524443 LB1524445 LB1524463 LB1524466 LB1524468 LB1524475 LB1524479 LB1524481¿ LB1524490 LB1524493 LB1525896 LB1525901 LB1525907 LB1526905 LB1527067 LB1527075 LB1530306 LB1530313 LB1531711 LB1531739 LB1533341 LB1533352 LB1536078 LB1536107 LB1537839 LB1537859 LB1539734 LB1539735 LB1540185

    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

    93