BEUDAMED
    FDA Enforcement Class I Ongoing

    IVENIX INFUSION SYSTEM, LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25). Large Volume Infusion Pump Administration Set.

    Recall: Z-0586-2026 · Reported December 10, 2025

    Enforcement

    Recall Number
    Z-0586-2026
    Event ID
    97941
    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 10, 2025
    Initiation Date
    November 3, 2025
    Classification Date
    December 3, 2025
    Address
    50 High St Ste 50, North Andover, MA, 01845-2620, United States

    Description

    IVENIX INFUSION SYSTEM, LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25). Large Volume Infusion Pump Administration Set.

    Reason

    Incorrect assembly of specific lot of LVP Primary Administration Set that could result in serious patient injury.

    Code Info

    Product Code: SET-0032-25; UDI: 00811505030214; Lot No. FA25B03126.

    Distribution

    US Nationwide distribution in the states of IL, MD, MI, OK, SC, TX, VA & WI.

    Quantity

    483 cases (12,075 eaches)