FDAFDA · Food and drugs·Recall number Z-1008-2015
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.
Published February 18, 2015 · Recall initiated: December 4, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's 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
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Teleflex, Inc.
- Distributor
- Distributed in the states of FL, MI, WV, and KS.
- Lot
- Batch Numbers: 201321, 201323, and 201324.
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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