BEUDAMED
    FDA Enforcement Class I Ongoing

    TRACH KIT W/HYDROGEN & SALI

    Recall: Z-1044-2024 · Reported February 28, 2024

    Enforcement

    Recall Number
    Z-1044-2024
    Event ID
    93551
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Cardinal Health 200, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 28, 2024
    Initiation Date
    December 4, 2023
    Classification Date
    February 16, 2024
    Address
    3651 Birchwood Dr, N/A, Waukegan, IL, 60085-8337, United States

    Description

    TRACH KIT W/HYDROGEN & SALI

    Reason

    Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.

    Code Info

    REF 47802; Lot Numbers: 2201103364, 2201103464, 2201804164, 2201804264, 2204627064, 2204627364, 2204801164, 2205309664, 2205309764, 2206020664, 2206020764, 2206731664, 2206731764, 2208117464, 2208117564, 2208828064, 2208828164, 2212326364, 2213014664, 2215107664, 2215808564, 2222816264, 2216523964, 2217209464, 2219323864, 2217915264, 2219326264, 2219910964, 2221312264, 2221312164, 2222816164, 2222816364, 2223528364, 2223528464, 2224243164, 2224243264, 2224929764, 2224929864, 2225515664, 2226320664, 2225515764, 2226320764, 2227034464, 2229112364, 2227725164, 2227725264, 2227022264, 2231226564, 2231914264, 2305711364, 2305711464, 2306201964, 2300121564, 2305706564, 2306622764, 2307909364, 2307305764, 2307305664, 2307909464, 2308600464, 2310101364, 2310101464, 2311517164, 2310900364

    Distribution

    US and EMEA, Japan, Latin America

    Quantity

    661,560 units