Smiths Medical ASD, Inc. recalls 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…

Recall date

October 31, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1145-2017

FDA classification

Class III

Brand / firm

Smiths Medical ASD, Inc.

Sold / distributed

Internationally to Finland

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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.