BEUDAMED
    FDA Recall Terminated

    Bard Luminexx 3 Biliary Stent and Delivery System

    Recall: Z-1585-05 · Initiated July 21, 2005

    Recall

    Recall Number
    Z-1585-05
    Event Number
    32921
    Firm
    Bard Peripheral Vascular Inc
    FEI Number
    2020394
    Product Code
    FGE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 21, 2005
    Posted
    September 24, 2005
    Terminated
    October 23, 2008
    Address
    1625 W 3rd St, Tempe, AZ, 85281-2438

    Description

    Bard Luminexx 3 Biliary Stent and Delivery System

    Reason

    Angiomed Material Review Board reviewing the manufacturing process observed an increase in the internal scrap rate (failure mode: broken stent struts) of nitinol stents and determined the root cause to be a manufacturing change from polymer to aluminum fixtures.

    Action

    Recall notification letter dated July 21, 2005, was sent to Hospital and Physician consignees.

    Distribution

    Nationwide

    Quantity

    102