BEUDAMED
    FDA Enforcement Class II Ongoing

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

    Recall: Z-0848-2026 · Reported December 10, 2025

    Enforcement

    Recall Number
    Z-0848-2026
    Event ID
    97939
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Fresenius Kabi USA, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    December 10, 2025
    Initiation Date
    November 3, 2025
    Classification Date
    December 1, 2025
    Address
    50 High St Ste 50, North Andover, MA, 01845-2620, United States

    Description

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

    Reason

    Downstream Occlusion alarms may occur during procedures using low flow infusion rates when a check valve* is added to the Ivenix Administration Set.

    Code Info

    Model Number: LVP-0004. UDI-DI: 00811505030320.

    Distribution

    US Nationwide distribution in the sates of CA, CO, FL, GA, ID, IL, MD, MI, MN, MS, NE, NJ, NV, OK, OR, SC, TX, UT, VA, WA, WI.

    Quantity

    15,862 units