BEUDAMED
    FDA Enforcement Class I Ongoing

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

    Recall: Z-2224-2026 · Reported June 10, 2026

    Enforcement

    Recall Number
    Z-2224-2026
    Event ID
    98945
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Fresenius Kabi USA, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    June 10, 2026
    Initiation Date
    May 6, 2026
    Classification Date
    May 29, 2026
    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

    Fresenius Kabi has been made aware via customer complaints that dropping or severe jarring of the Ivenix LVP may cause damage to internal components that may not be apparent or readily visible and the devices therefore remained in service. More specifically, drops or jarring on a hard surface can cause the touchscreen input cable to loosen, resulting in unintended touchscreen behavior on the LVP, including random screen touches and/or lack of screen responsiveness to user input. Under the reported failure condition, unintended touch inputs may register at arbitrary screen locations without user interaction. These inputs occur intermittently and without a predictable pattern.

    Code Info

    Model Number: LVP-0004; UDI-DI: 00811505030320; All Serial/Lot Numbers:

    Distribution

    Domestic: CA, CO, FL, GA, ID, IL, MD, MI, MI , MN, MO, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA, WI, WI;

    Quantity

    18,444