United StatesThe affected product is the Ivenix Infusion System (IIS) Large Volume Pump, model LVP-0004 (UDI-DI 00811505030320), distributed nationwide in the United States. It was recalled because downstream occlusion alarms may occur during procedures using low flow infusion rates when a check valve is added to the Ivenix Administration Set.
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.
The hazard
Downstream Occlusion alarms may occur during procedures using low flow infusion rates when a check valve* is added to the Ivenix Administration Set.
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 sates of CA, CO, FL, GA, ID, IL, MD, MI, MN, MS, NE, NJ, NV, OK, OR, SC, TX, UT, 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)