BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-2224-2026 · Initiated May 6, 2026

    Recall

    Recall Number
    Z-2224-2026
    Event Number
    98945
    Firm
    Fresenius Kabi USA, LLC
    FEI Number
    3014732157
    Product Code
    FRN
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    May 6, 2026
    Posted
    May 29, 2026
    Address
    50 High St, Ste 50, North Andover, MA, 01845-2620

    Description

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

    Reason

    Fresenius Kabi has been made aware via customer complaints that dropping or severe jarring of the Ivenix LVP may cause damage to internal components that may not be apparent or readily visible and the devices therefore remained in service. More specifically, drops or jarring on a hard surface can cause the touchscreen input cable to loosen, resulting in unintended touchscreen behavior on the LVP, including random screen touches and/or lack of screen responsiveness to user input. Under the reported failure condition, unintended touch inputs may register at arbitrary screen locations without user interaction. These inputs occur intermittently and without a predictable pattern.

    Action

    On May 6, 2026 URGENT - Medical Device Field Correction letters were sent to customers. Required Actions for Healthcare Providers 1. If a unit has been dropped or severely jarred, remove it from service, even if no damage is visible. 2. Once you have removed the pump from service, or if you have questions about whether to do so after a drop, please contact Fresenius Kabi customer support at [email protected] or (855) 354-6387. 3. Post enclosed Safety Tip Sheet, Proper Handling of the Ivenix Large Volume Pump (LVP) notice within your facilities to ensure that all ancillary staff are informed of this notification and trained on the action to remove any dropped or severely jarred devices from use. 4. Notify other users if applicable. If your facility distributes or transfers devices to other locations, notify all anticipated users of this correction.

    Distribution

    Domestic: CA, CO, FL, GA, ID, IL, MD, MI, MI , MN, MO, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA, WI, WI;

    Quantity

    18,444