BEUDAMED
    FDA Recall Open, Classified

    BARD SURESTEP INTERMITTENT CATHETER TRAY, 14Fr, REF INTS16C

    Recall: Z-0667-2022 · Initiated January 27, 2022

    Recall

    Recall Number
    Z-0667-2022
    Event Number
    89288
    Firm
    C.R. Bard Inc
    FEI Number
    1018233
    Product Code
    KOD
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    January 27, 2022
    Address
    8195 Industrial Blvd NE, Covington, GA, 30014-1497

    Description

    BARD SURESTEP INTERMITTENT CATHETER TRAY, 14Fr, REF INTS16C

    Reason

    There is a potential to leak from the catheter where it connects to the drain bag

    Action

    The firm initiated the recall on 01/27/2022 by letter. The letter explained the issue and the hazard and requested consignee destroy any product on hand. Distributors were directed to destroy all product on hand and to notify their customers of the recall.

    Distribution

    US Nationwide distribution in the states of GA, ME, NJ, WI, MN, SD, CO, ND, ID, IL, FL, LA, MD, PA, OH, NE.

    Quantity

    1620 units