BEUDAMED
    FDA Recall Terminated

    HOLDEX Single-Use Holder PP closed pack. Greiner Bio-One Austria Gmbh. A sterile single-use disposable holder with an off-center female luer at the top of the holder and epoxy bonded stainless steel needle on the underside of the holder, recommended for use with commercially available butterfly and luer needles in routine venipuncture procedures.

    Recall: Z-2957-2011 · Initiated June 29, 2011

    Recall

    Recall Number
    Z-2957-2011
    Event Number
    59352
    Firm
    Greiner Bio-One North America, Inc.
    FEI Number
    3001451379
    Product Code
    FMI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 29, 2011
    Posted
    August 8, 2011
    Terminated
    November 3, 2011
    Address
    4238 Capital Dr, Monroe, NC, 28110

    Description

    HOLDEX Single-Use Holder PP closed pack. Greiner Bio-One Austria Gmbh. A sterile single-use disposable holder with an off-center female luer at the top of the holder and epoxy bonded stainless steel needle on the underside of the holder, recommended for use with commercially available butterfly and luer needles in routine venipuncture procedures.

    Reason

    At removal of the tube from the holder, the needle may dislodge and blood spill can occur.

    Action

    Greiner Bio-One North America, Inc. sent a "Recall HOLDEX Single Use Holder PP" letter dated June 29, 2011 to all affected customers. The letter instructed customers stop distributing the product immediately. A Product Disposition form was provided to be completed and returned to Greiner Bio-One at which time upon receipt, arrangements for product return to Greiner Bio-One will be made for replacement or credit. They were requested to provide a list of their customers to Greiner Bio-One that received the affected item. For additional information call Greiner Bio-One at (888) 266-3883.

    Distribution

    Nationwide Distribution including the states of CA, GA, IL, KS, MA, IL, PA and VA.

    Quantity

    142,400 pieces