BEUDAMED
    FDA Enforcement Class II 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 · Reported August 1, 2018

    Enforcement

    Recall Number
    Z-2556-2018
    Event ID
    80276
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    CryoLife, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    August 1, 2018
    Initiation Date
    June 4, 2018
    Classification Date
    July 26, 2018
    Termination Date
    February 8, 2019
    Address
    1655 Roberts Blvd NW, N/A, Kennesaw, GA, 30144-3632, United States

    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.

    Code Info

    Model Number BG3510-5-J, Lot Number 18MJX002

    Distribution

    Distribution is to Japan

    Quantity

    855 Total