BEUDAMED
    FDA Enforcement Class II Ongoing

    Catalog No. 8888160341; Umbilical Vessel Catheter 5 French single lumen

    Recall: Z-1873-2025 · Reported June 4, 2025

    Enforcement

    Recall Number
    Z-1873-2025
    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. 8888160341; Umbilical Vessel Catheter 5 French single 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) 10192253040319; UDI-DI (box) 50192253040317 Lots 2427700158 2425600066 2433000005 2427700160 2425600067 2425600070 2415100113 2425600071 2427700159 2415100110 2412100093 2433000095 2425600069 2425600077 2415100116 2425600063 2425600074 2415100115 2415100114 2412100096 2425600072 2425600075 2404400061 2425600064 2415100106 2425600076 2415100107 2415100112 2425600073 2425600065 2404400062 2404400065 2415100093 2415100109 2415100111 2433000094

    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

    51378