BEUDAMED
    FDA Enforcement Class II Ongoing

    SureStep Foley Tray System Bardex I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303316A

    Recall: Z-2589-2025 · Reported September 24, 2025

    Enforcement

    Recall Number
    Z-2589-2025
    Event ID
    97273
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    C.R. Bard Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 24, 2025
    Initiation Date
    July 17, 2025
    Classification Date
    September 18, 2025
    Address
    8195 Industrial Blvd Ne, N/A, Covington, GA, 30014-1497, United States

    Description

    SureStep Foley Tray System Bardex I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303316A

    Reason

    Foley catheter trays have incorrect inserts, user may think:1)Silicone, when it's natural rubber latex, or 2)Natural rubber latex with infection control coating, when it's silicone hydrogel with antimicrobial coating, or 3)Natural latex with infection control, when it's silicone hydrogel coated without antimicrobial coating, which may cause infection and/or local and/or systemic allergic reaction

    Code Info

    Lot#NGJX6399

    Distribution

    US Nationwide distribution including in the states of NC, FL, NY, MA, MN, TX, CA, OH, MI, WA, NJ, IL, ID, SC, IN, OK, OR, AL, VA, HI, MO, MS, MD, AZ, KY, GA, IA, CO, NM, PA, ME, UT, NE.

    Quantity

    4,300