Recall Z-2374-2016— Teleflex Medical
Class II · Terminated
Class II FDA medical device recall by Teleflex Medical, initiated 2015-12-03, terminated 2017-04-14. FDA's recall record names no specific 510(k) clearance for this event. Product: 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: Cracks may occur at the 15mm and 22mm ISO female connector..
- Recalling firm
- Teleflex Medical
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-12-03
- Terminated
- 2017-04-14
- Firm location
- Morrisville, NC, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.