BEUDAMED
    FDA Enforcement Class II Ongoing

    medex TranStar 84in (213cm) Single Monitoring Kit 10/EA, Product Code REF MX9505T

    Recall: Z-0192-2025 · Reported October 30, 2024

    Enforcement

    Recall Number
    Z-0192-2025
    Event ID
    95438
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Smiths Medical ASD, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    N/A
    Report Date
    October 30, 2024
    Initiation Date
    September 24, 2024
    Classification Date
    October 23, 2024
    Address
    6000 Nathan Ln N, N/A, Minneapolis, MN, 55442-1690, United States

    Description

    medex TranStar 84in (213cm) Single Monitoring Kit 10/EA, Product Code REF MX9505T

    Reason

    Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.

    Code Info

    UDI/DI 50351688503990 (case), 10351688503992 (pouch), Lot Numbers: 4277670, 4287645, 4287649, 4299776, 4277696, 4308930, 4299811, 4308934, 4299812, 4323148, 4264943, 4264939, 4277694, 4264950, 4299779, 4308962, 4323175, 4328515, 4299788, 4299789, 4299790, 4299801, 4299802, 4308954, 4308959, 4308963, 4321917, 4308947, 4334499, 4299786, 4355732, 4355735, 4346115, 4299780, 4355730, 4355727, 4334501, 4346096, 4346097, 4346124, 4355733, 4346109, 4355728, 4355740, 4355750, 4355749, 4355746, 4346120, 4355757, 4355753

    Distribution

    Worldwide distribution.

    Quantity

    1160168 units