United StatesThe affected product is the Ivenix Infusion System (IIS), Large Volume Pump, Model LVP-0004 (UDI-DI 00811505030320), serial numbers 2318600378, 2321600176, 2333300359, 2403001383, 9242756430, and 9243097443, distributed in Minnesota. It was recalled because the device can register “phantom” touches in the lower-left corner of the touchscreen during operation.
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. Serial Numbers: 2318600378, 2321600176, 2333300359, 2403001383, 9242756430, 9243097443.
The hazard
Potential issue that can cause the device to register "phantom" touches in the lower-left corner of the touchscreen during operation.
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 state of Minnesota.
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)