Reported Aug 17, 2016 · Terminated

Servo Humidifier 163, Model 01-06-8125-8, REF 6419365 Product Usage: A heat and moisture condenser (artifical nose) is…

Teleflex Medical

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

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 Medical · 3015 Carrington Mill Blvd · Morrisville, NC · 27560-5437

Is this the product you have?

    • Servo Humidifier 163
    • Model 01-06-8125-8
  • REF 6419365 Product UsageA heat and moisture condenser (artifical 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 humidity gases breathed in by the patient
Lot codes and dates
    • Lots 201450
    • 201451
    • 201452
    • 201504
Amount recalled
2,700 ea.

Where it was sold

Why it was recalled

Cracks may occur at the 15mm and 22mm ISO female connector.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

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

Read the FDA (openFDA device enforcement) notice

Notice updated Apr 14, 2017 · Data as of Sep 19, 5:19 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.