BEUDAMED
    FDA Recall Terminated

    Bard UroForce Balloon Dilation Catheter with Glissando Coating * BARD * C.R. Bard, Inc. Covington, Georgia 30014 * 1-800-526-4455 * Sterile/EO

    Recall: Z-0268-06 · Initiated November 3, 2005

    Recall

    Recall Number
    Z-0268-06
    Event Number
    34037
    Firm
    C.R. Bard, Inc., Urological Division
    FEI Number
    1018233
    Product Code
    EZN
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 3, 2005
    Posted
    December 3, 2005
    Terminated
    January 24, 2006
    Address
    8195 Industrial Blvd Ne, Covington, GA, 30014-1497

    Description

    Bard UroForce Balloon Dilation Catheter with Glissando Coating * BARD * C.R. Bard, Inc. Covington, Georgia 30014 * 1-800-526-4455 * Sterile/EO

    Reason

    There is a potential for the lumen to collapse and prevent passage over a guidewire.

    Action

    Consignees were notified via overnight courier on 11/7&8/2005

    Distribution

    Nationwide, Belgium, Canada

    Quantity

    480 units