United StatesHotline Fluid Warming Set (single-use), List Number L-70, UDI-DI 30695085407007, in Lot Numbers 4293568, 4293569, 4297510, 4297509, 4326087, 4337724, 4337725, 4346349 is affected. ICU Medical recalled 39,750 units distributed worldwide because the company identified an increased likelihood of leakage in these lots due to potentially inadequate solvent application at the tubing-to-return connector bond.
What's being recalled
Hotline Fluid Warming Set, single use device, is designed to warm blood and intravenous fluids and deliver them to the patient's intravenous access site at normothermic temperatures under gravity flow conditions, List Number L-70
Recalling firm: ICU Medical Inc., Minneapolis, MN, United States.
How to identify it
UDI-DI: 30695085407007; Lot Numbers: 4293568, 4293569, 4297510, 4297509, 4326087, 4337724, 4337725, 4346349
The hazard
ICU Medical became aware of an increased likelihood of leakage in specific Lots of L-70 HOTLINE Fluid Warming Sets due to potentially inadequate solvent application at the tubing to return connector bond.
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
Worldwide - US Nationwide distribution.
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)
Canada