BEUDAMED
    FDA Recall Terminated

    BD Direct Draw Adapters, Catalog Number 364896.

    Recall: Z-1463-06 · Initiated June 21, 2006

    Recall

    Recall Number
    Z-1463-06
    Event Number
    35831
    Firm
    Becton Dickinson & Company
    FEI Number
    2243072
    Product Code
    KSR
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 21, 2006
    Posted
    September 9, 2006
    Terminated
    June 7, 2007
    Address
    1 Becton Dr, Franklin Lakes, NJ, 07417-1815

    Description

    BD Direct Draw Adapters, Catalog Number 364896.

    Reason

    Firm received complaints indicating failure of the Non-Patient (NP) sleeve to function properly. This sleeve covers the cannula and prevents leakage during blood collection.

    Action

    BD sent out recall notifications on 6/21/2006 to distributors and their direct account customers.

    Distribution

    World wide-Products are distributed nationwide to distributors and direct accounts. The products are also distributed internationally to the following locations: Japan, Australia, Canada, Hong Kong, New Zealand. For European distribution, the products are shipped to Temse located in Belgium who handles the recall. Temse has been identified as recalling only the following products and lots: Catalog Number 364896 (Direct Draw Adapter), lots 5311376, 5312193, 5312201. Catalog Number 367300 (Luer Adapter), lots 5307894, 5307896, 5307900. Government accounts include the VAMC in Erie, PA;

    Quantity

    234,450 units