Fresenius Kabi Usa, Llc: Ivenix Infusion System (iis), Large Volume Pump, Model Number: Lvp-0004

Recall Summary Fresenius Kabi is recalling the Ivenix Infusion System Large Volume Pump (Model LVP-0004) because dropping or jarring the device can damage internal components that may not be visible, potentially causing the touchscreen to malfunction. When damaged, the touchscreen may register random touches or stop responding to user input without warning. The affected devices were distributed across multiple U.S. states including California, Texas, Florida, and others.

Recalling firm

Fresenius Kabi USA, LLC

Product

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...

Classification

Class I

Category

medical device recall

Country

United States

Agency

U.S. Food and Drug Administration

Recall date

2026-05-06

Status

Ongoing

Areas affected

CA, CO, FL, GA, ID, IL, MD, MI, MN, MS, MO, NE, ...

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;

Official recall notice from U.S. Food and Drug Administration

Recall details on Nibble Recalls: https://trynibble.app/recalls/60f77f82-692f-4bb5-8f8b-bb69cb9c753d