BEUDAMED
    FDA Enforcement Class II Ongoing

    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 · Reported February 13, 2019

    Enforcement

    Recall Number
    Z-0800-2019
    Event ID
    81750
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Bard Medical Division
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 13, 2019
    Initiation Date
    December 6, 2018
    Classification Date
    February 5, 2019
    Address
    8195 Industrial Blvd NE, Covington, GA, 30014-1497, United States

    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.

    Code Info

    Product Code A319418AM; Lot NGCT1929; Exp. Date 11/30/2018

    Distribution

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

    Quantity

    450 units