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.
Reported: August 17, 2016 Initiated: December 3, 2015 #Z-2374-2016
Product Description
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.
Reason for Recall
Cracks may occur at the 15mm and 22mm ISO female connector.
Details
- Recalling Firm
- Teleflex Medical
- Units Affected
- 2,700 ea.
- Distribution
- US Nationwide Distribution in the states of FL, KS and WV.
- Location
- Morrisville, NC
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Teleflex Medical. Units affected: 2,700 ea..
Why was this product recalled? ▼
Cracks may occur at the 15mm and 22mm ISO female connector.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 17, 2016. Severity: Moderate. Recall number: Z-2374-2016.
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