BEUDAMED
    FDA Recall Terminated

    BD Vacutainer CPT Cell Preparation Tube with Sodium Heparin, 8 mL, 16 x 125 mm, Catalog #REF 362753, Lot #4063409 with expiry 03/2015, intended for the collection of whole blood and the separation of mononuclear cells.

    Recall: Z-2542-2014 · Initiated July 3, 2014

    Recall

    Recall Number
    Z-2542-2014
    Event Number
    68730
    Firm
    Becton Dickinson & Company
    FEI Number
    2243072
    Product Code
    JCF
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    July 3, 2014
    Posted
    August 22, 2014
    Terminated
    May 3, 2016
    Address
    1 Becton Dr, Franklin Lakes, NJ, 07417-1815

    Description

    BD Vacutainer CPT Cell Preparation Tube with Sodium Heparin, 8 mL, 16 x 125 mm, Catalog #REF 362753, Lot #4063409 with expiry 03/2015, intended for the collection of whole blood and the separation of mononuclear cells.

    Reason

    BD has initiated the recall of its Vacutainer CPT Cell Preparation Tube due to poor separation, resulting in a reduced number of recovered mononuclear cells.

    Action

    BD issued an "Urgent Voluntary Product Recall" Letter dated July 3, 2014 and a "Notice of Return" Form to all affected customers.

    Distribution

    US and Foreign

    Quantity

    296,160 tubes