BEUDAMED
    FDA Enforcement Class II Terminated

    Vacuette Quickshield Complete Plus, 21G x 1 (0.8 x 25 mm), Greiner bio-one. The Quick shield Complete Plus is intended to be used only with Vacuette Blood collection Tubes as a system in routine venipuncture procedures. They are for single-use only and should only be used by adequately trained healthcare personnel in accordance with instructions for use.

    Recall: Z-1935-2012 · Reported July 11, 2012

    Enforcement

    Recall Number
    Z-1935-2012
    Event ID
    62447
    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
    July 11, 2012
    Initiation Date
    April 2, 2012
    Classification Date
    July 3, 2012
    Termination Date
    February 27, 2013
    Address
    4238 Capital Dr, N/A, Monroe, NC, 28110, United States

    Description

    Vacuette Quickshield Complete Plus, 21G x 1 (0.8 x 25 mm), Greiner bio-one. The Quick shield Complete Plus is intended to be used only with Vacuette Blood collection Tubes as a system in routine venipuncture procedures. They are for single-use only and should only be used by adequately trained healthcare personnel in accordance with instructions for use.

    Reason

    : The Quickshield Complete Plus may have a defect (split at the base), which can cause the green safety shield attachment of the Quickshield holder to be loose and unstable.

    Code Info

    Item #450239, Lot #G110601I and Item #450235, Lot #G110302J.

    Distribution

    Nationwide Distribution including IL, MS, OH, PA, TN and VA.

    Quantity

    19.5 cases (5,850 pieces) and 244 cases (73,200 pieces)= 263.5 (73258 pieces total)