BEUDAMED
    FDA Enforcement Class II Ongoing

    CADD Medication Cassette Reservoir, 50mL, FS, Product Code 21-7301-24

    Recall: Z-0013-2025 · Reported October 30, 2024

    Enforcement

    Recall Number
    Z-0013-2025
    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, 50mL, FS, Product Code 21-7301-24

    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 10610586027215, Lot Numbers: 4042839, 4040248, 4034021, 4052405, 4034022, 4037748, 4042841, 4034019, 4037749, 4040247, 3983339, 3983338, 3983340, 4013367, 4013366, 3988532-ENG, 3983337, 4052406, 4042840, 4052407, 4052408, 4042842, 4048891, 4052409

    Distribution

    Worldwide distribution.

    Quantity

    119535 units