BEUDAMED
    FDA Enforcement Class II Terminated

    BioGlue Surgical Adhesive, Model BG3510-5-G

    Recall: Z-0384-2022 · Reported December 22, 2021

    Enforcement

    Recall Number
    Z-0384-2022
    Event ID
    88929
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    CryoLife, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 22, 2021
    Initiation Date
    October 7, 2021
    Classification Date
    December 15, 2021
    Termination Date
    October 23, 2023
    Address
    1655 Roberts Blvd Nw, Kennesaw, GA, 30144-3632, United States

    Description

    BioGlue Surgical Adhesive, Model BG3510-5-G

    Reason

    Product is not approved for use in the EU and should not have been distributed in the EU.

    Code Info

    Model BG3510-5-G, Lot BG000255

    Distribution

    Distribution in the European Union only (Germany/Switzerland)

    Quantity

    156 5-pack box units