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

Company / brand

Fresenius Kabi USA, LLC

Product

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

Reason / hazard

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.

Classification

Class I

Status

Ongoing

Distribution / sold at

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

Recall initiated

2026-05-06

Code info

Model Number: LVP-0004; UDI-DI: 00811505030320; All Serial/Lot Numbers:

Product quantity

18,444

Voluntary mandated

Voluntary: Firm initiated

City

North Andover

State

MA

Country

United States

Event id

98945

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