BEUDAMED
    FDA Recall 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 · Initiated February 1, 2013

    Recall

    Recall Number
    Z-0835-2013
    Event Number
    64321
    Firm
    Greiner Bio-One North America, Inc.
    FEI Number
    3001451379
    Product Code
    FMI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 1, 2013
    Posted
    February 15, 2013
    Terminated
    October 29, 2013
    Address
    4238 Capital Dr, Monroe, NC, 28110

    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.

    Action

    Greiner Bio-One sent a notification letter dated January 31, 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to stop distributing the affected product, complete the attached Product Disposition form and fax to GBO at 800-726-0052 or email to [email protected]. GBO will contact customers for the return of the affected product after receiving the attached Product Disposition form. Customers were requested to provide the names of customers who may have received the product. For questions call 800-515-8112.

    Distribution

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

    Quantity

    192,000 pieces (192 cases)