BEUDAMED
    FDA Recall Terminated

    Bard E LUMINEXX Biliary Stent, Size: 12mm x 40mm, Product Number: ZBM12040.

    Recall: Z-1463-2009 · Initiated December 23, 2008

    Recall

    Recall Number
    Z-1463-2009
    Event Number
    50745
    Firm
    Bard Peripheral Vascular Inc
    FEI Number
    2020394
    Product Code
    FGE
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    December 23, 2008
    Posted
    June 17, 2009
    Terminated
    April 2, 2012
    Address
    1625 W 3rd St, Tempe, AZ, 85281-2438

    Description

    Bard E LUMINEXX Biliary Stent, Size: 12mm x 40mm, Product Number: ZBM12040.

    Reason

    This action is being taken because a label for an indicated use was applied to product sizes that are not approved for that use. The incorrect indication for use label stated "Now Approved for Vascular Use".

    Action

    Bard Peripheral Vascular, Inc. (BVP) sent an "Urgent - Product Recall Notice" letter to consignees dated December 22, 2008 outlining the reason for the recall. In the letter, customers were informed to check all inventory locations, stop any further distribution of and return affected product to BPV. Consignees were to complete the enclosed Recall and Effectiveness Check Form and fax to 1-800-440-5376 or send information by phone at 1-800-321-4254 extension 2727 or e-mail at [email protected].

    Distribution

    Nationwide Distribution including states of AL, AR, CA, CT, DE, FL, GA, IL, IN, KY, MA, MD, MO, MS, NC, ND, NJ, NM, NY, OH, PA, TN, TX, VA and WI.

    Quantity

    94 units total for all product codes