United StatesThe Ivenix Infusion System (IIS) Large Volume Pump, Model LVP-0004 (UDI‑DI 00811505030320; all serial/lot numbers) sold in multiple U.S. states is being recalled. Fresenius Kabi reports that drops or severe jarring can loosen the touchscreen input cable, which may cause intermittent unintended touchscreen behavior, including random touches or lack of responsiveness, with inputs registering without user interaction.
What's being recalled
Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004
Recalling firm: Fresenius Kabi USA, LLC, North Andover, MA, United States.
How to identify it
Model Number: LVP-0004; UDI-DI: 00811505030320; All Serial/Lot Numbers:
The 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.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Domestic: CA, CO, FL, GA, ID, IL, MD, MI, MI , MN, MO, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA, WI, WI;
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)