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
    • 201321
    • 201323
    • and 201324
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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Mar 21, 2017 · Data as of Sep 19, 4:47 PM UTC

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