BEUDAMED
    FDA Recall Terminated

    BD Vacutainer Safety-Lok Blood Collection Set with Preattached Holder. Color green. 21 Gauge. Translucent, integrated protective shield that provides one-handed activation immediately after use, 0.75 in needle length, 12 in tubing, Luer adapter and holder, wings, sterile.

    Recall: Z-0777-2007 · Initiated March 20, 2007

    Recall

    Recall Number
    Z-0777-2007
    Event Number
    37710
    Firm
    Becton Dickinson & Company
    FEI Number
    2243072
    Product Code
    JKA
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 20, 2007
    Posted
    May 10, 2007
    Terminated
    July 25, 2007
    Address
    1 Becton Dr, Franklin Lakes, NJ, 07417-1815

    Description

    BD Vacutainer Safety-Lok Blood Collection Set with Preattached Holder. Color green. 21 Gauge. Translucent, integrated protective shield that provides one-handed activation immediately after use, 0.75 in needle length, 12 in tubing, Luer adapter and holder, wings, sterile.

    Reason

    The BD Vacutainer Safety-Lok Blood Collection Set with Preattached Holder has a problem where the non-patient needle (in the holder) may become separated from the hub and remain the stopper of an evacuated blood collection tube.

    Action

    Recall letters were sent to customers on 3/11/2007 via a third party, West Inc., Appleton, WI who will coordinate the mailing to all consignees.

    Distribution

    Nationwide and Canada.

    Quantity

    147,200 units