BEUDAMED
    FDA Enforcement Class II Ongoing

    CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24

    Recall: Z-0010-2025 · Reported October 30, 2024

    Enforcement

    Recall Number
    Z-0010-2025
    Event ID
    95305
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Smiths Medical ASD Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 30, 2024
    Initiation Date
    June 26, 2024
    Classification Date
    October 18, 2024
    Address
    6000 Nathan Ln N, N/A, Minneapolis, MN, 55442-1690, United States

    Description

    CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24

    Reason

    Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medication bag and tubing due to a production equipment malfunction. This could result in a medication leakage.

    Code Info

    UDI/DI 1061058602228, Lot Numbers: 3977441, 4013370, 3983314, 4013371, 4013369, 4013372, 4025948, 4033993, 4037444, 4040238

    Distribution

    Worldwide distribution.

    Quantity

    125928 units