United StatesThe LVP software of the Ivenix Infusion System (IIS), Product Code LVP-SW-0005, UDI-DI 00811505030122, Software Version 5.10.2 (32 systems) distributed in multiple US states including CA, CO, FL, GA, ID, IL, MD, MI, MN, MO, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA and WI is affected. It was recalled because a potential software anomaly can cause the pump to report a false battery-health value (typically 69%) and trigger a battery-depletion alarm that will shut down the pump unless it is reconnected to AC mains power.
What's being recalled
LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005.
Recalling firm: Fresenius Kabi USA, LLC, North Andover, MA, United States.
How to identify it
Product Code LVP-SW-0005. UDI-DI: 00811505030122. Software Version 5.10.2
The hazard
Potential software anomaly that can cause the pump to report a false battery-health value (typically 69%) and trigger a battery-depletion alarm that will shut down the pump unless it is reconnected to AC mains power.
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
US Nationwide distribution in the states of CA, CO, FL, GA, GA, ID, IL, MD, MI, MN, MO, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA, 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)