BEUDAMED
    FDA Enforcement Class II Ongoing

    Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.

    Recall: Z-0378-2026 · Reported November 5, 2025

    Enforcement

    Recall Number
    Z-0378-2026
    Event ID
    97554
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Fresenius Kabi USA, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    November 5, 2025
    Initiation Date
    September 3, 2025
    Classification Date
    October 28, 2025
    Address
    50 High St Ste 50, N/A, North Andover, MA, 01845-2620, United States

    Description

    Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.

    Reason

    Potential issue that can cause the device to register "phantom" touches in the lower-left corner of the touchscreen during operation.

    Code Info

    Model Number: LVP-0004. UDI-DI: 00811505030320. Serial Numbers: 2318600378, 2321600176, 2333300359, 2403001383, 9242756430, 9243097443.

    Distribution

    US Nationwide distribution in the state of Minnesota.

    Quantity

    6 units