BEUDAMED
    FDA Enforcement Class I Ongoing

    Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled administration of fluids to patients.

    Recall: Z-0885-2026 · Reported December 24, 2025

    Enforcement

    Recall Number
    Z-0885-2026
    Event ID
    98009
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Fresenius Kabi USA, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    December 24, 2025
    Initiation Date
    November 14, 2025
    Classification Date
    December 16, 2025
    Address
    50 High St Ste 50, North Andover, MA, 01845-2620, United States

    Description

    Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled administration of fluids to patients.

    Reason

    Software version 5.10.1 and earlier contain anomalies that have the potential to cause serious patient harm or death.

    Code Info

    Software Versions 5.10.1 and prior; UDI: 00811505030122.

    Distribution

    US (Domestic) distribution: CA, CO, FL, GA, ID, IL, MD, MI, MN, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA & WI.

    Quantity

    30 units