FDADecember 4, 2014device

MAQUET Servo Humidifier 163; Model No.: 01-06-8125-8, catalog no. XKC01-06-8125-8. A heat and moisture condenser (artificial nose) is a device intended to be positioned over a tracheotomy (a surgically created opening in the throat) or tracheal tube (a tube inserted into the trachea) to warm and ...

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

The hazard

Connector mount cracks which may lead to a leak failure during use and necessitate immediate replacement in the breathing circuit. If leak exists and is left untreated, patient may be deprived of adequate anesthetic gases over a period of time and serious adverse health consequences may occur.

What to do

FDA enforcement status: Terminated

Brands named

teleflex

Recall history

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

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