BEUDAMED
    FDA Recall Terminated

    Bard Platinum Class II Flat Wire Stone Basket, Ureteral Stone Dislodger, Rx only, Sterile, C.R.Bard, Inc., Covington, GA 30014

    Recall: Z-0315-04 · Initiated December 22, 2003

    Recall

    Recall Number
    Z-0315-04
    Event Number
    28010
    Firm
    C.R. Bard, Inc., Urological Division
    FEI Number
    1018233
    Product Code
    FFL
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 22, 2003
    Posted
    January 9, 2004
    Terminated
    September 1, 2004
    Address
    8195 Industrial Blvd Ne, Covington, GA, 30014-1497

    Description

    Bard Platinum Class II Flat Wire Stone Basket, Ureteral Stone Dislodger, Rx only, Sterile, C.R.Bard, Inc., Covington, GA 30014

    Reason

    Product packaging may contain holes compromising sterility.

    Action

    Consignees were notified by certified letter on 12/22/2003.

    Distribution

    Product was distributed Nationwide, Canada, Belgium and Japan

    Quantity

    12,684 units (total includes both types)