BEUDAMED
    FDA Enforcement Class II Terminated

    VACUETTE Safety Blood Collection Set + Luer Adapter, 23x12" Safety Blood Collect LA Product, Item number 450096. Usage: The Safety Blood Collection Set is used in routine venipuncture procedures.

    Recall: Z-0835-2013 · Reported February 27, 2013

    Enforcement

    Recall Number
    Z-0835-2013
    Event ID
    64321
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Greiner Bio-One North America, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 27, 2013
    Initiation Date
    February 1, 2013
    Classification Date
    February 15, 2013
    Termination Date
    October 29, 2013
    Address
    4238 Capital Dr, N/A, Monroe, NC, 28110, United States

    Description

    VACUETTE Safety Blood Collection Set + Luer Adapter, 23x12" Safety Blood Collect LA Product, Item number 450096. Usage: The Safety Blood Collection Set is used in routine venipuncture procedures.

    Reason

    The VACUETTE Safety Blood Collection Set + Luer Adapter may display leaking (small droplets) during use due to a crack on the luer connector piece.

    Code Info

    Lot No. 12H27

    Distribution

    US Nationwide Distribution in the states of FL, IL, KY, NY, NC, PA, OH, TX, VA

    Quantity

    192,000 pieces (192 cases)