Official recall notice

FDA DeviceClass IINotable

FDA Recall: Hotline Fluid Warming Set, single use device, is designed to warm blood and intravenous fluids and d

Recall date
2026-07-29
FDA class
Class II

Why it was recalled

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.

Product description

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.

Affected products

UDI-DI: 30695085407007; Lot Numbers: 4293568, 4293569, 4297510, 4297509, 4326087, 4337724, 4337725, 4346349

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