BEUDAMED
    FDA Recall Open, Classified

    Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005.

    Recall: Z-1048-2026 · Initiated November 21, 2025

    Recall

    Recall Number
    Z-1048-2026
    Event Number
    98106
    Firm
    Fresenius Kabi USA, LLC
    FEI Number
    3014732157
    Product Code
    FRN
    Status
    Open, Classified
    Root Cause
    Use error
    Initiated
    November 21, 2025
    Posted
    January 12, 2026
    Address
    50 High St, Ste 50, North Andover, MA, 01845-2620

    Description

    Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005.

    Reason

    Emphasizing instructions for LVP duration programming located in the IFU.

    Action

    An URGENT MEDICAL DEVICE CORRECTION notification dated 11/21/25 was sent to consignees notifying them of this safety alert. The notification reiterates instructions for administering infusions included in the device's IFU. Fresenius Kabi asks consignees to disseminate the notification to all users and any facilities where devices may have been further distributed for their awareness. Consignees with any questions are to contact Customer Support by email at [email protected] or by phone at 1-855-354-6387.

    Distribution

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

    Quantity

    30 units