BEUDAMED
    FDA Enforcement Class II Ongoing

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

    Recall: Z-2274-2026 · Reported June 10, 2026

    Enforcement

    Recall Number
    Z-2274-2026
    Event ID
    98699
    Classification
    Class II
    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
    February 4, 2026
    Classification Date
    May 29, 2026
    Address
    50 High St Ste 50, North Andover, MA, 01845-2620, United States

    Description

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

    Reason

    Potential for the Cassette Loading Lever to break.

    Code Info

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

    Distribution

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

    Quantity

    18,444 installed bases