BEUDAMED
    FDA Enforcement Class II Ongoing

    CardinalHealth Suction Canister Liner, MEDI-VAC CRD, REF 65651-510

    Recall: Z-0754-2024 · Reported January 24, 2024

    Enforcement

    Recall Number
    Z-0754-2024
    Event ID
    93628
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Cardinal Health 200, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 24, 2024
    Initiation Date
    December 21, 2023
    Classification Date
    January 18, 2024
    Address
    3651 Birchwood Dr, N/A, Waukegan, IL, 60085-8337, United States

    Description

    CardinalHealth Suction Canister Liner, MEDI-VAC CRD, REF 65651-510

    Reason

    The above-listed lots of Cardinal Health Medi-Vac CRD" Suction Canister Liners 1L may experience loss of suction on low or low intermittent suction settings, due to a misalignment of the liner with the outer hard canister.

    Code Info

    UDI/DI 50630140152649 (case), Lot Numbers: J308-602, J308-605, J308-609, J308-623, J308-624, J308-625, J308-628, J308-629, J308-630, J308-632, J308-633, J308-634, J308-635, J308-636, J308-637, J308-640, J308-642, J308-607, J308-643, J309-603, J309-607, J309-623, J309-627, J309-630, J309-632, J309-635, J309-636, J309-637, J310-601, J310-609, J310-621, J310-622, J310-626, J310-627, J310-641, J310-642, J310-643, J310-644

    Distribution

    US, Canada, Australia and New Zealand

    Quantity

    3505730 units