Recall Z-1008-2015— Teleflex, Inc.
Class I · Terminated
Class I FDA medical device recall by Teleflex, Inc., initiated 2014-12-04, terminated 2017-03-21. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. Reason: 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..
- Recalling firm
- Teleflex, Inc.
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2014-12-04
- Terminated
- 2017-03-21
- Firm location
- Wayne, PA, United States
Product description
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.
Reason for recall
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.
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