BEUDAMED
    FDA Recall Terminated

    BD Vacutainer Push Button Blood collection Sets with Pre-Attached Holder; Catalog Number: 368656; 23 g X12 " PBBCS w/PAH (Preattached), BD Diagnostics, Franklin Lakes, NJ

    Recall: Z-0590-2008 · Initiated November 20, 2007

    Recall

    Recall Number
    Z-0590-2008
    Event Number
    45965
    Firm
    Becton Dickinson & Company
    FEI Number
    2243072
    Product Code
    JKA
    Status
    Terminated
    Root Cause
    Material/Component Contamination
    Initiated
    November 20, 2007
    Posted
    January 23, 2008
    Terminated
    September 8, 2008
    Address
    1 Becton Dr, Franklin Lakes, NJ, 07417-1815

    Description

    BD Vacutainer Push Button Blood collection Sets with Pre-Attached Holder; Catalog Number: 368656; 23 g X12 " PBBCS w/PAH (Preattached), BD Diagnostics, Franklin Lakes, NJ

    Reason

    Safety Mechanism Failure: the safety mechanism of the BD Vacutainer Push Button Collection Set with Pre-attached holder cannot be activated; thus the needle cannot retract into the rear barrel.

    Action

    BD sent Recall notification letters, Urgent Class II Product Recall, to customers and distributors on 12/10/07 through a third party, West Inc., Appleton, Wi. Mailings were sent return receipt requested. Letters requested immediate inventory search and product return. Contact number for questions was given as 1-800-631-0174

    Distribution

    Worldwide-USA and Canada

    Quantity

    769,200 USA; 1,300 Canada