BEUDAMED
    FDA Recall Terminated

    BioGlue Surgical Adhesive, Model/Catalog Number BG3510-5-J

    Recall: Z-2623-2017 · Initiated May 19, 2017

    Recall

    Recall Number
    Z-2623-2017
    Event Number
    77369
    Firm
    CryoLife, Inc.
    FEI Number
    3001451326
    Product Code
    MUQ
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    May 19, 2017
    Terminated
    February 8, 2019
    Address
    1655 Roberts Blvd NW, Kennesaw, GA, 30144-3632

    Description

    BioGlue Surgical Adhesive, Model/Catalog Number BG3510-5-J

    Reason

    The courtesy labels in 9 boxes of BioGlue were incorrectly labeled as lot 17MJX007 instead of lot 17MJX002.

    Action

    Firm notified customer on approximately 06/02/2017 via letter. Instructions included to inspect inventory on hand, to destroy the incorrect courtesy labels and replace them with the correct labels what were shipped.

    Distribution

    Product distributed in Japan.

    Quantity

    705 single pack boxes