BEUDAMED
    FDA Recall Terminated

    Bard Access Systems, Inc., Fastrac* "Pull" Gastric Access Port Safety System, REF 007052, 16F, Sterile.

    Recall: Z-2196-2009 · Initiated December 4, 2008

    Recall

    Recall Number
    Z-2196-2009
    Event Number
    50678
    Firm
    C.R. Bard Access Systems, Inc
    FEI Number
    3006260740
    Product Code
    KNT
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    December 4, 2008
    Posted
    September 15, 2009
    Terminated
    November 9, 2011
    Address
    5425 Amelia Earhart Dr, Salt Lake City, UT, 84116-3713

    Description

    Bard Access Systems, Inc., Fastrac* "Pull" Gastric Access Port Safety System, REF 007052, 16F, Sterile.

    Reason

    Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal during use, necessitating retrieval of the remaining piece.

    Action

    Bard contacted all 1,883 worldwide customers who received the distributed suspect 467 product code lots, comprising 177, 614 units that were either not expired or were still available in the field. These will be returned by the customer to Bard Access Systems. 1-800-290-1689.

    Distribution

    Worldwide, including USA, Belgium, Canada, Australia, and Japan.

    Quantity

    177,614 units