BEUDAMED
    FDA Recall Terminated

    Bard Magic 3 Antibacterial Hydrophilic Intermittent Catheter Female, 14 FR (30/box), Rx Only intended for urinary bladder drainage in patients requiring catheterization for management of incontinence, voiding dysfunction, and surgical procedures.

    Recall: Z-3226-2017 · Initiated July 28, 2017

    Recall

    Recall Number
    Z-3226-2017
    Event Number
    78031
    Firm
    C.R. Bard, Inc.
    FEI Number
    1018233
    Product Code
    MJC
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    July 28, 2017
    Terminated
    August 25, 2020
    Address
    8195 Industrial Blvd NE, Covington, GA, 30014-1497

    Description

    Bard Magic 3 Antibacterial Hydrophilic Intermittent Catheter Female, 14 FR (30/box), Rx Only intended for urinary bladder drainage in patients requiring catheterization for management of incontinence, voiding dysfunction, and surgical procedures.

    Reason

    Specific lots labeled as an Antibacterial Hydrophilic Intermittent Catheter may lack the hydrophilic coating.

    Action

    Customers were notified via letter on 07/28/2017. Instructions included to examine their inventory and identify affected product and notify customers if further distributed. Bard Medical Division asks that customers contact customer service at 1-800-526-4455 if any affected units do not meet their needs.

    Distribution

    Distribution to AL, AZ, CA, FL, GA, IL, IN, KS, KY, MA, MO, NC, NJ, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA.

    Quantity

    45,270 units