BEUDAMED
    FDA Recall Terminated

    Bardex Foley Catheter, 22 Fr 40cc- 20cc Ribbed Balloons, Coleman Model Red Latex, 3 Way Radiopaque, Lubricath Coated, Sterile, Single Use Device, C.R. Bard, Inc., Covington, GA 30014. The catheter is an open whistle tip with two eyes on the same side. It is made of red latex for added catheter stiffness and radiopacity, with a Lubricath hydrophilic coating. This product has 3 lumens; a lumen for drainage, a lumen for inflation of the bladder balloon, and a lumen for inflation of the prostatic balloon.

    Recall: Z-1144-03 · Initiated August 29, 2002

    Recall

    Recall Number
    Z-1144-03
    Event Number
    26828
    Firm
    C.R. Bard, Inc., Urological Division
    FEI Number
    1018233
    Product Code
    MJC
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 29, 2002
    Posted
    August 21, 2003
    Terminated
    September 19, 2003
    Address
    8195 Industrial Blvd NE, Covington, GA, 30014

    Description

    Bardex Foley Catheter, 22 Fr 40cc- 20cc Ribbed Balloons, Coleman Model Red Latex, 3 Way Radiopaque, Lubricath Coated, Sterile, Single Use Device, C.R. Bard, Inc., Covington, GA 30014. The catheter is an open whistle tip with two eyes on the same side. It is made of red latex for added catheter stiffness and radiopacity, with a Lubricath hydrophilic coating. This product has 3 lumens; a lumen for drainage, a lumen for inflation of the bladder balloon, and a lumen for inflation of the prostatic balloon.

    Reason

    On some units the inflation valve labeling is reversed on the Prostate and Bladder balloon inflation ports.

    Action

    Consignees were notified by letter on 8/29/2002. They were advised to pretest the catheter prior to inserting the catheter into the urethra.If the pretest indicates that the catheter balloons do not inflate as labeled, they were advised not to use the product and to contact Bard Medical Division Field Assurance Manager to have the product returned and credited.

    Distribution

    The product was distributed nationwide, Canada, Belgium and Germany.

    Quantity

    1461 units