BEUDAMED
    FDA Enforcement Class III Terminated

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

    Recall: Z-0198-2016 · Reported November 11, 2015

    Enforcement

    Recall Number
    Z-0198-2016
    Event ID
    72398
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    C.R. Bard, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 11, 2015
    Initiation Date
    October 2, 2015
    Classification Date
    November 2, 2015
    Termination Date
    August 1, 2016
    Address
    8195 Industrial Blvd NE, N/A, Covington, GA, 30014-1497, United States

    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.

    Code Info

    Lot 53620131

    Distribution

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

    Quantity

    4,170 each