BEUDAMED
    FDA Recall Terminated

    BioGlue Spreader Tip, 12mm, Sterile, RX Only. Product Usage: BioGlue is indicated for use as an adjunct to standard methods of achieving hemostasis (such as sutures and staples) in adult patients in open surgical repair of large vessels (such as aorta, femoral , and carotid arteries).

    Recall: Z-2556-2018 · Initiated June 4, 2018

    Recall

    Recall Number
    Z-2556-2018
    Event Number
    80276
    Firm
    CryoLife, Inc.
    FEI Number
    3001451326
    Product Code
    MUQ
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    June 4, 2018
    Terminated
    February 8, 2019
    Address
    1655 Roberts Blvd NW, Kennesaw, GA, 30144-3632

    Description

    BioGlue Spreader Tip, 12mm, Sterile, RX Only. Product Usage: BioGlue is indicated for use as an adjunct to standard methods of achieving hemostasis (such as sutures and staples) in adult patients in open surgical repair of large vessels (such as aorta, femoral , and carotid arteries).

    Reason

    The CryoLife L6318 (Label, BioGlue 12mm Spreader Tip, Indicator Label 2 1/8" x 1 1/4") was incorrectly applied to the Syringe Applicator Tip pouches and Syringe Spreader Tip pouches were not included in the boxes.

    Action

    CyroLife notified their customers on/about 06/04/2018 via Urgent - Important Product Removal letter. instructions indicated that affected pouches have been returned to CryoLife, Inc. Any questions/clarifications regarding this removal are directed to contact 800-438-8285 or by email to fieldassurance@c ryolife.com.

    Distribution

    Distribution is to Japan

    Quantity

    855 Total