BEUDAMED
    FDA Enforcement Class II Terminated

    Magic3 Hydrophilic-coated Female Intermittent Urinary Catheter 14 Fr in the Insertion Supply Kit, Product Code 51614S. Intermittent catheter.

    Recall: Z-2388-2015 · Reported August 26, 2015

    Enforcement

    Recall Number
    Z-2388-2015
    Event ID
    71722
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    C.R. Bard, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 26, 2015
    Initiation Date
    July 7, 2015
    Classification Date
    August 14, 2015
    Termination Date
    July 21, 2017
    Address
    8195 Industrial Blvd NE, Covington, GA, 30014-1497, United States

    Description

    Magic3 Hydrophilic-coated Female Intermittent Urinary Catheter 14 Fr in the Insertion Supply Kit, Product Code 51614S. Intermittent catheter.

    Reason

    Potential breach of the sterile barrier packaging.

    Code Info

    Lot Number 53620387, 53621274, 53621279

    Distribution

    Nationwide Distribution-including AL, AZ, AR, CA, CO, CT, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NV, NH, NJ, NY, NC, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WV, WI AND DC.

    Quantity

    534,972 each