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.
- FDAEndotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 1120820552023-05-25
- FDAEndotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 1120820502023-05-25
- FDAEndotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 1120800952023-05-25
- FDAEndotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 1120800552023-05-25
- FDARUSCHELIT Safety Clear Tracheal Tube, oral/nasal, Magill, REF 1124800302023-05-25
- FDAEndotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 1120801002023-05-25
- FDAEndotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 1120820902023-05-25
- FDAEndotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 1120820602023-05-25
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