FDAFDA · Food and drugs·Recall number Z-2374-2016
Servo Humidifier 163, Model 01-06-8125-8, REF 6419365 Product Usage: A 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.
Published August 17, 2016 · Recall initiated: December 3, 2015
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
Cracks may occur at the 15mm and 22mm ISO female connector.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Teleflex Medical
- Distributor
- US Nationwide Distribution in the states of FL, KS and WV.
- Lot
- Lots 201450, 201451, 201452, 201504
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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