BEUDAMED
    FDA Recall Terminated

    Greiner bio-one * Vacuette Tube * 9C Coagulation Sodium, Citrate 3.2%, * 3.5mL * blue cap-black ring * 24 racks of 50, 1200 pcs in total * non-ridged * Sandwich Tube * 454332 * B050609 * 2007-05 * Sterile * manufactured by: Greiner Bio-one North America, Inc., 4238 Capital Drive, Monroe, NC 28110, USA

    Recall: Z-1498-06 · Initiated August 2, 2006

    Recall

    Recall Number
    Z-1498-06
    Event Number
    36027
    Firm
    Greiner Bio-One North America, Inc.
    FEI Number
    3001451379
    Product Code
    GIM
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 2, 2006
    Posted
    September 13, 2006
    Terminated
    January 11, 2007
    Address
    4238 Capital Dr, Monroe, NC, 28110-7681

    Description

    Greiner bio-one * Vacuette Tube * 9C Coagulation Sodium, Citrate 3.2%, * 3.5mL * blue cap-black ring * 24 racks of 50, 1200 pcs in total * non-ridged * Sandwich Tube * 454332 * B050609 * 2007-05 * Sterile * manufactured by: Greiner Bio-one North America, Inc., 4238 Capital Drive, Monroe, NC 28110, USA

    Reason

    Coagulation tubes found with no additive.

    Action

    Consignees were notified by letter via fax starting 08/02/2006.

    Distribution

    Nationwide

    Quantity

    160 cases (192000 pieces)