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FDA (Device enforcement)Recalled 2026-06-24class ii

ICU Medical Inc.: 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

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.

Details from the source

Reason for recall: 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. Distribution: Worldwide - US Nationwide distribution. Quantity: 39,750 units Lot/code info: UDI-DI: 30695085407007; Lot Numbers: 4293568, 4293569, 4297510, 4297509, 4326087, 4337724, 4337725, 4346349

UPC codes

30695085407007

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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