BEUDAMED
    FDA Recall Terminated

    Quick Shield with Snappy Safety Holder, Greiner bio-one. The VACUETTE QUICKSHIELD with SNAPPY Tube Holder is intended to be used only with the VACUETTE Blood Collection Needles and VACUETTE Blood Collection Tubes as a system in routine venipuncture procedures. These devices are to be used by properly trained healthcare professionals only in accordance with these instructions.

    Recall: Z-0179-2012 · Initiated August 11, 2011

    Recall

    Recall Number
    Z-0179-2012
    Event Number
    59918
    Firm
    Greiner Bio-One North America, Inc.
    FEI Number
    3001451379
    Product Code
    FMI
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    August 11, 2011
    Posted
    November 9, 2011
    Terminated
    March 20, 2012
    Address
    4238 Capital Dr, Monroe, NC, 28110

    Description

    Quick Shield with Snappy Safety Holder, Greiner bio-one. The VACUETTE QUICKSHIELD with SNAPPY Tube Holder is intended to be used only with the VACUETTE Blood Collection Needles and VACUETTE Blood Collection Tubes as a system in routine venipuncture procedures. These devices are to be used by properly trained healthcare professionals only in accordance with these instructions.

    Reason

    Reports of the Vacuette QuickShield Safety Holders breaking during use due to a crack at the holder hub.

    Action

    Greiner Bio-One sent a "QUICKSHIELD WITH SAFETY HOLDER" notification letter dated August 11, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to stop distributing and using the affected products. A Product Disposition Form was attached for customers to complete and return for replacements. Contact the firm at 888-266-3883 for questions concerning this recall.

    Distribution

    Nationwide Distribution-USA (nationwide) including the states of CO, IL, KY, NY, PA and VA.

    Quantity

    443,950 pieces