Device 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.
Z-2374-2016
Product summary
- Firm
- Teleflex Medical
- Event
- Event 74681
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2,700 ea.
- Official record key
device-enforcement:Z-2374-2016
Official wording
Reason: Cracks may occur at the 15mm and 22mm ISO female connector.
Code information: Lots 201450, 201451, 201452, 201504
Distribution pattern: US Nationwide Distribution in the states of FL, KS and WV.
Derived failure modes
-
Unknown
Cracks may occur at the 15mm and 22mm ISO female connector.