TELEFLEX MEDICAL INC recalls HUDSON RCI COMFORT FLO Corrugated Humidification System with Remote Temperature Port, REF 2416, humidifier nebulizer kit

Recall date

December 13, 2019

Source

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

Recall number

Z-1113-2020

FDA classification

Class I

Brand / firm

TELEFLEX MEDICAL INC

Sold / distributed

nationwide

Why it was recalled

There is the potential for water to flood the column and enter the circuit under circumstances where an abnormal pressure differential is created between the water bottle and the column during high flow oxygen therapy.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

HUDSON RCI COMFORT FLO Corrugated Humidification System with Remote Temperature Port, REF 2416, humidifier nebulizer kit