FDA Enforcement
Class II
Terminated
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.
Recall: Z-2374-2016
·
Reported August 17, 2016
Enforcement
- Recall Number
- Z-2374-2016
- Event ID
- 74681
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Teleflex Medical
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- August 17, 2016
- Initiation Date
- December 3, 2015
- Classification Date
- August 9, 2016
- Termination Date
- April 14, 2017
- Address
- 3015 Carrington Mill Blvd, Morrisville, NC, 27560-5437, United States
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
Cracks may occur at the 15mm and 22mm ISO female connector.
Code Info
Lots 201450, 201451, 201452, 201504
Distribution
US Nationwide Distribution in the states of FL, KS and WV.
Quantity
2,700 ea.