BEUDAMED
    FDA Recall Open, Classified

    medex TranStar SINGLE 84IN SET WITH ANTI-SHUNT STOPCOCK 10/EA, Product Code REF MXG300243R1

    Recall: Z-0203-2025 · Initiated September 24, 2024

    Recall

    Recall Number
    Z-0203-2025
    Event Number
    95438
    Firm
    Smiths Medical ASD, Inc.
    FEI Number
    3012307300
    Product Code
    DPT
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    September 24, 2024
    Posted
    October 23, 2024
    Address
    6000 Nathan Ln N, Minneapolis, MN, 55442-1690

    Description

    medex TranStar SINGLE 84IN SET WITH ANTI-SHUNT STOPCOCK 10/EA, Product Code REF MXG300243R1

    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.

    Action

    Smiths medical issued an URGENT MEDICAL DEVICE REMOVAL notice to its consignees on 09/24/2024 via traceable mailing. The notice explained the issue, potential risk, and requested the destruction of all affected product. Distributors were directed to forward the notice to their customers.

    Distribution

    Worldwide distribution.

    Quantity

    3080 units