FDA DeviceClass IINotable
FDA Recall: Hotline Fluid Warming Set, single use device, is designed to warm blood and intravenous fluids and d
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.
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.
Remedy
39,750 units
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