BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-2388-2015 · Initiated July 7, 2015

    Recall

    Recall Number
    Z-2388-2015
    Event Number
    71722
    Firm
    C.R. Bard, Inc.
    FEI Number
    1018233
    Product Code
    KOD
    Status
    Terminated
    Root Cause
    Unknown/Undetermined by firm
    Initiated
    July 7, 2015
    Posted
    August 14, 2015
    Terminated
    July 21, 2017
    Address
    8195 Industrial Blvd NE, Covington, GA, 30014-1497

    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.

    Action

    A recall notice was sent to consignees on 7/7/2015 asking them to discontinue use of the product. The letter to the distributors requested a sub-recall. Both letters included a response form to be returned to Bard.

    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