BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-0378-2026 · Initiated September 3, 2025

    Recall

    Recall Number
    Z-0378-2026
    Event Number
    97554
    Firm
    Fresenius Kabi USA, LLC
    FEI Number
    3014732157
    Product Code
    FRN
    Status
    Open, Classified
    Root Cause
    Process change control
    Initiated
    September 3, 2025
    Posted
    October 28, 2025
    Address
    50 High St, Ste 50, North Andover, MA, 01845-2620

    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.

    Action

    Fresenius Kabi notified the consignee on 09/03/2025 via email. The consignee was instructed to review the list of affected units and identify any on hand for return, remove all affected units from circulation pending repair and isolate them to avoid use, notify customers/personnel if the units were further distributed or transferred, and ensure all relevant personnel are aware. A Fresenius Kabi service representative will contact the consignee arrange for the return of affected units for repair.

    Distribution

    US Nationwide distribution in the state of Minnesota.

    Quantity

    6 units