BEUDAMED
    FDA Enforcement Class II Ongoing

    medex TranStar KIDS KIT 19IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9543

    Recall: Z-0197-2025 · Reported October 30, 2024

    Enforcement

    Recall Number
    Z-0197-2025
    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 KIDS KIT 19IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9543

    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 50351688503099 (case), 10351688503091 (pouch), Lot Numbers: 4297925, 4340497, 4355387

    Distribution

    Worldwide distribution.

    Quantity

    800 units