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
ICU Medical Inc.
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. FDA Class II recall.
The remedy
Follow FDA guidance
About this recall
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
Affected identifiers
Check these against the label on your unit. An identifier match is how a recall is confirmed, not just suspected.
Model UDI-DI: 30695085407007Model Lot Numbers: 4293568Model 4293569Model 4297510Model 4297509Model 4326087Model 4337724Model 4337725Model 4346349UPC 30695085407007Would you have heard about this one?
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