BEUDAMED
    FDA Recall Terminated

    Bard Dispoz-A-Bag, Disposable Urinary Leg Bags, with Flip-Flo Drainage Valve, 19 oz or 32 oz with a Fabric Leg Strap, C.R.Bard, Inc., Covington, GA 30014, Contents Sterile.

    Recall: Z-0732-03 · Initiated March 25, 2003

    Recall

    Recall Number
    Z-0732-03
    Event Number
    25894
    Firm
    C.R. Bard, Inc., Urological Division
    FEI Number
    1018233
    Product Code
    FAQ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 25, 2003
    Posted
    April 17, 2003
    Terminated
    August 7, 2003
    Address
    8195 Industrial Blvd NE, Covington, GA, 30014

    Description

    Bard Dispoz-A-Bag, Disposable Urinary Leg Bags, with Flip-Flo Drainage Valve, 19 oz or 32 oz with a Fabric Leg Strap, C.R.Bard, Inc., Covington, GA 30014, Contents Sterile.

    Reason

    There is a potential for package seals to be open after sterilization.

    Action

    The oldest lot that the firm has confirmed in inventory that had an open seal was manufactured in October 2002. Based upon depletion analysis with distributor inventory being three months and an additional assurance of 12 months, the firm is removing product manufactured from October 1, 2001 through February 28, 2003. Consignees were notified via certified letter with Business Reply Form attached for effectiveness check. Consignees were advised to remove/segregate, and return affected product for credit.

    Distribution

    Product was distributed to 16 doctors, 79 hospitals, 280 distributors, and 53 sales representatives nationwide.

    Quantity

    283, 277 units