BEUDAMED
    FDA Recall Terminated

    Holdex + Butterfly, Blood Collection Set, Single use only. Sterile, Manufactured by : CA Greiner & Sohne Gmbh, Bad Haller Str. 32, A-4550 Kremsmunster, Austria.

    Recall: Z-0388-04 · Initiated December 16, 2003

    Recall

    Recall Number
    Z-0388-04
    Event Number
    28126
    Firm
    Greiner VACUETTE North America
    FEI Number
    3001451379
    Product Code
    FPA
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 16, 2003
    Posted
    January 29, 2004
    Terminated
    June 7, 2004
    Address
    4238 Capital Dr, Monroe, NC, 28110-7681

    Description

    Holdex + Butterfly, Blood Collection Set, Single use only. Sterile, Manufactured by : CA Greiner & Sohne Gmbh, Bad Haller Str. 32, A-4550 Kremsmunster, Austria.

    Reason

    Product may have a defective connection.

    Action

    Distributors and end users were notified by certified mail or fax on 12/16/2003.

    Distribution

    The product was shipped to medical facilities in IN, NY and TX.

    Quantity

    5 cases (5000 pieces)