Fresenius Kabi USA, LLC recalls Ivenix Infusion System (IIS)

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.

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

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 Ivenix_support@fresenius-kabi.com 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.

• FDA enforcement recordOfficial FDA database entry for Z-2224-2026
• FDA 510(k) clearance · K183311The device's official FDA premarket clearance record
• FDA device classification · FRNOfficial FDA classification for this device type
• CFR regulation · 21 CFR 880.5725The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Fresenius Kabi USA, LLCSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.