BEUDAMED
    FDA Recall Terminated

    Antibacterial Hydro Personal Catheter, Male 12 Fr, Product Code 63512, sold in boxes of 30 units

    Recall: Z-0198-2016 · Initiated October 2, 2015

    Recall

    Recall Number
    Z-0198-2016
    Event Number
    72398
    Firm
    C.R. Bard, Inc.
    FEI Number
    1018233
    Product Code
    MJC
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    October 2, 2015
    Posted
    November 2, 2015
    Terminated
    August 1, 2016
    Address
    8195 Industrial Blvd NE, Covington, GA, 30014-1497

    Description

    Antibacterial Hydro Personal Catheter, Male 12 Fr, Product Code 63512, sold in boxes of 30 units

    Reason

    Incorrect unit labeling. The case label and shelf box are correct, Product Code 63512 and Catheter Size 12 French. The unit label (catheter package) may state Product Code 63516 and Catheter Size 16 French.

    Action

    Bard sent a Customer Notification Letter dated September 29 to customers via FedEx with proof of delivery notice. The letter identified the product, the problem, and the action to be taken by the customer. The consignees were instructed to carry out the notification to the user level. Customers with questions were instructed to contact BMD at 1-770-784-6471.

    Distribution

    Nationwide Distribution including CA, FL, IL, MO, NJ, OR, PA, TX & WA.

    Quantity

    4,170 each