BEUDAMED
    FDA Recall Terminated

    BioGlue Surgical Adhesive, Model BG3510-5-G

    Recall: Z-0384-2022 · Initiated October 7, 2021

    Recall

    Recall Number
    Z-0384-2022
    Event Number
    88929
    Firm
    CryoLife, Inc.
    FEI Number
    3001451326
    Product Code
    MUQ
    Status
    Terminated
    Root Cause
    No Marketing Application
    Initiated
    October 7, 2021
    Terminated
    October 23, 2023
    Address
    1655 Roberts Blvd Nw, Kennesaw, GA, 30144-3632

    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.

    Action

    A customer letter titled "Urgent Field Safety Notice BioGlue" was issued 10/07/2021 to the impacted consignee. All product is to be returned for final disposition. A customer reply letter should be completed and submitted to the recalling firm.

    Distribution

    Distribution in the European Union only (Germany/Switzerland)

    Quantity

    156 5-pack box units