United StatesIVENIX Infusion System LVP Primary Administration Set (Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site, Qty 25) — Product Code SET-0032-25; UDI 00811505030214; Lot No. FA25B03126 — distributed nationwide in IL, MD, MI, OK, SC, TX, VA and WI (483 cases, 12,075 eaches) is being recalled by Fresenius Kabi USA, LLC. The recall is for an incorrect assembly of a specific lot that could result in serious patient injury.
What's being recalled
IVENIX INFUSION SYSTEM, LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25). Large Volume Infusion Pump Administration Set.
Recalling firm: Fresenius Kabi USA, LLC, North Andover, MA, United States.
How to identify it
Product Code: SET-0032-25; UDI: 00811505030214; Lot No. FA25B03126.
The hazard
Incorrect assembly of specific lot of LVP Primary Administration Set that could result in serious patient injury.
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 IL, MD, MI, OK, SC, TX, VA & 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)