United StatesThe Ivenix Infusion System (IIS) LVP Software LVP-SW-0005 used for controlled administration of fluids is affected; affected units are identified by software versions 5.10.1 and earlier and UDI 00811505030122. Fresenius Kabi USA recalled the product because software version 5.10.1 and earlier contain anomalies that have the potential to cause serious patient harm or death.
What's being recalled
Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled administration of fluids to patients.
Recalling firm: Fresenius Kabi USA, LLC, North Andover, MA, United States.
How to identify it
Software Versions 5.10.1 and prior; UDI: 00811505030122.
The hazard
Software version 5.10.1 and earlier contain anomalies that have the potential to cause serious patient harm or death.
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 (Domestic) distribution: CA, CO, FL, GA, ID, IL, MD, MI, MN, 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)