BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-2623-2017 · Reported July 5, 2017

    Enforcement

    Recall Number
    Z-2623-2017
    Event ID
    77369
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    CryoLife, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 5, 2017
    Initiation Date
    May 19, 2017
    Classification Date
    June 23, 2017
    Termination Date
    February 8, 2019
    Address
    1655 Roberts Blvd NW, N/A, Kennesaw, GA, 30144-3632, United States

    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.

    Code Info

    Lot Code 17MJX002, Model/Catalog Number BG3510-5-J

    Distribution

    Product distributed in Japan.

    Quantity

    705 single pack boxes