FDAOctober 31, 2016device

HOTLINE Blood and Fluid Warmer, Mole l HL-90. Designed for use with the Hotline Fluid Warming Set (L-80, L-70 and L-70N) to warm blood and intravenous (I.V.) fluids and deliver them to the patient's intravenous access site at normothermic temperatures under gravity flow conditions.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

HOTLINE Blood and Fluid Warmers included Greek and Danish language labeling instead of the required Finnish labeling.

What to do

FDA enforcement status: Terminated

Brands named

smiths medical asdsmithssmiths medical

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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