Reported Feb 18, 2015 · Terminated
MAQUET Servo Humidifier 163; Model No.: 01-06-8125-8, catalog no. XKC01-06-8125-8. A heat and moisture condenser…
Teleflex, Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Teleflex, Inc. · 550 E Swedesford Rd Ste 400 · Wayne, PA · 19087-1601
Is this the product you have?
- 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.
- Lot codes and dates
- Batch Numbers
201321201323and 201324
- Batch Numbers
- Amount recalled
- 18
Where it was sold
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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