United StatesThe Ivenix Infusion System (IIS), LVP Software LVP-SW-0005 (Product Code LVP-SW-0005; UDI 00811505030122; software versions 5.10.2 and prior), 30 units distributed across CA, CO, FL, GA, ID, IL, MD, MI, MN, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA, WI, is being recalled by Fresenius Kabi USA, LLC. It was recalled because of issues emphasizing instructions for LVP duration programming located in the Instructions for Use (IFU).
What's being recalled
Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005.
Recalling firm: Fresenius Kabi USA, LLC, North Andover, MA, United States.
How to identify it
Product Code: LVP-SW-0005; UDI: 00811505030122; Software versions 5.10.2 and prior.
The hazard
Emphasizing instructions for LVP duration programming located in the IFU.
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, ID, IL, MD, MI, MI, MN, 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)