BEUDAMED
    FDA Recall Open, Classified

    SureStep Foley Tray System BARD Lubri-Sil Foley Catheter Tray, REF: A942216

    Recall: Z-2591-2025 · Initiated July 17, 2025

    Recall

    Recall Number
    Z-2591-2025
    Event Number
    97273
    Firm
    C.R. Bard Inc
    FEI Number
    1018233
    Product Code
    MJC
    Status
    Open, Classified
    Root Cause
    Labeling mix-ups
    Initiated
    July 17, 2025
    Posted
    September 18, 2025
    Address
    8195 Industrial Blvd Ne, Covington, GA, 30014-1497

    Description

    SureStep Foley Tray System BARD Lubri-Sil Foley Catheter Tray, REF: A942216

    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

    Action

    On 7/17/2025, recall notices were mailed and emailed to Recall Coordinator, Director of Nursing, Director of Purchasing, Director of Risk Management, and Distributors who were asked to do the following: 1) It is recommended that clinicians discontinue the use of impacted devices and find alternative catheters with the appropriate characteristics required for their patients to continue therapy and avoid potential health risks related to this issue. 2) Quarantine and discard all devices within your facility s control per your facility s procedures. 3) Share this notice with any users of the product within your facilities to ensure they are also aware of this Medical Device Recall (Correction). 4) If you have purchased this product through a distributor, please contact this distributor to request appropriate credit or order alternate replacement product. 5) Complete and return the attached Customer Response Form via email to [email protected] In addition, distributors were asked to: a) Identify all customers within your distribution network that purchased any affected product as defined in this notification. Provide a copy of the attached customer letter to all customers to advise them of this field action notification on the recalling firm's behalf. b) Contact recalling firm if you require assistance with credits to be issued for discard-ed products or for replacement product options. If you require assistance contact the firm: Medical Information Services: 1-800-555-7422, [email protected]; Technical Support: 1-844-823-5433, [email protected]

    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

    3670