BEUDAMED
    FDA Recall Open, Classified

    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 · Initiated May 12, 2025

    Recall

    Recall Number
    Z-1869-2025
    Event Number
    96880
    Firm
    Fresenius Kabi USA, LLC
    FEI Number
    3014732157
    Product Code
    FPA
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    May 12, 2025
    Posted
    June 6, 2025
    Address
    50 High St, Ste 50, North Andover, MA, 01845-2620

    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.

    Action

    Consignees received an "URGENT - VOLUNTARY RECALL" notification via email dated 5/11/25. This notification instructs consignees to discontinue use and distribution of affected devices immediately. Consignees are to check their inventory for affected devices and place them in quarantine until product can be returned for replacement. The provided recall notification is to be distributed to users of the affected devices. Consignees are instructed to return the completed Customer Reply Form via fax or email to facilitate return of affected devices for replacement. Consignees with any questions can contact Fresenius Kabi by phone at 855-354-6387x1 or by email at [email protected].

    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)