BEUDAMED
    FDA Enforcement Class I Ongoing

    IVENIX INFUSION SYSTEM LVP Blood Products Administration Set, Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter, 15 mL. Intravascular Administration Set.

    Recall: Z-1869-2025 · Reported June 18, 2025

    Enforcement

    Recall Number
    Z-1869-2025
    Event ID
    96880
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Fresenius Kabi USA, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    June 18, 2025
    Initiation Date
    May 12, 2025
    Classification Date
    June 6, 2025
    Address
    50 High St Ste 50, North Andover, MA, 01845-2620, United States

    Description

    IVENIX INFUSION SYSTEM LVP Blood Products Administration Set, Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter, 15 mL. Intravascular Administration Set.

    Reason

    Mis-assembly error of Blood Products Administrations Sets where the 200-micron drip chamber filter may be incorrectly positioned and unable to filter out large blood particulates.

    Code Info

    Model No. SET-0014-20; UDI 20811505030034; Lot No. FA24K05015.

    Distribution

    US distribution: CA, CO, DE, GA, IL, MD, MI, MN, MS, NC, NJ, NV, OK, SC, TX, VA, WA & WI.

    Quantity

    14,280 units (724 cases)