FDAOctober 25, 2016device

NORMFlow H-110 Irrigation Fluid Warmer, Continental Europe, Model H-1100, Reorder H-1100-INT-230. Product Usage: NORMOFLO¿ H-1100 Irrigation Fluid Warmers has been designed for safe, in-line warming of irrigating fluids as they are administered to patients. The Fluid Warmer utilizes a solution re...

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

The hazard

Smiths Medical became aware that that one (1) NORMOFLO¿ H-1100 Irrigation Fluid Warmers was incorrectly labelled with Spanish language labels instead of English labels. Specifically five (5) labels were incorrect; the Operators Manual, Outer Base Box label, Pole Assembly Box label, and two (2) O-ring Lube labels.

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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