FDA-Device2015-02-18Class I
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 humidify gases breathed in by a patient.
Teleflex, Inc.
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.
Sold states
Distributed in the states of FL, MI, WV, and KS.
Affected count
18
Manufactured in
550 E Swedesford Rd Ste 400, N/A, Wayne, PA, United States
Products
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 humidify gases breathed in by a patient.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1008-2015Don't want to check this manually?
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