BEUDAMED
    FDA Enforcement Class II Ongoing

    Catalog No. 8888160556; Umbilical Vessel Catheter 5 French dual lumen

    Recall: Z-1874-2025 · Reported June 4, 2025

    Enforcement

    Recall Number
    Z-1874-2025
    Event ID
    96783
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Cardinal Health 200, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 4, 2025
    Initiation Date
    May 2, 2025
    Classification Date
    May 29, 2025
    Address
    3651 Birchwood Dr, N/A, Waukegan, IL, 60085-8337, United States

    Description

    Catalog No. 8888160556; Umbilical Vessel Catheter 5 French dual lumen

    Reason

    Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.

    Code Info

    UDI-DI (ea) 10192253040364; UDI-DI (box) 50192253040362 Lots 2424900133 2424900134 2424900135 2435200126 2435200127 2435200129 2435200123 2435200124

    Distribution

    Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, NC, NJ, NM, NY, OH, OK, OR, PA, PR, RI, SD, TN, TX, UT, VA, WA, WI, WV and the countries of Brazil, Canada, Chile, Colombia, Singapore, South Africa.

    Quantity

    10438