BEUDAMED
    FDA Recall Open, Classified

    BARD SureStep Foley Tray System Bardex I.C. Complete Care Temperature Sensing Infection Control Foley Catheter with Bard Hydrogel and Bacteria-Guard Silver Alloy Coating. Sterile. Intended for use in the drainage and/or collection and/or measurement of urine.

    Recall: Z-0800-2019 · Initiated December 6, 2018

    Recall

    Recall Number
    Z-0800-2019
    Event Number
    81750
    Firm
    Bard Medical Division
    FEI Number
    1018233
    Product Code
    MJC
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    December 6, 2018
    Address
    8195 Industrial Blvd NE, Covington, GA, 30014-1497

    Description

    BARD SureStep Foley Tray System Bardex I.C. Complete Care Temperature Sensing Infection Control Foley Catheter with Bard Hydrogel and Bacteria-Guard Silver Alloy Coating. Sterile. Intended for use in the drainage and/or collection and/or measurement of urine.

    Reason

    Some SureStep" Foley Tray Systems with product catalog number A319418AM and lot number NGCT1929 contain vented sample ports that may have an increased likelihood of leaking urine from the vent on the sample port.

    Action

    Bard Medical Division notified customers on about 12/06/2018 via "MEDICAL DEVICE PRODUCT NOTIFICATION" letter. Customers were instructed to examine their inventory and identify any product subject to the recall, product return is not required, and if product was further distributed or transferred to notify those customers and include a copy of the medical device communication letter provided. Questions can be directed to Customer Service at 1-800-526-4455 or [email protected].

    Distribution

    US Nationwide Distribution io KY, NE, GA, FL, MS, IN, IL, VA, OK, TX, NM, IL, VA, PA, CA, NV.

    Quantity

    450 units