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
- Recall Number
- Z-2374-2016
- Event Number
- 74681
- Firm
- Teleflex Medical
- FEI Number
- 3005747797
- Product Code
- BYD
- Status
- Terminated
- Root Cause
- Release of Material/Component prior to receiving test results
- Initiated
- December 3, 2015
- Posted
- August 9, 2016
- Terminated
- April 14, 2017
- Address
- 3015 Carrington Mill Blvd, Morrisville, NC, 27560-5437
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.
Cracks may occur at the 15mm and 22mm ISO female connector.
Inmed, a division of Teleflex sent an Urgent Field Safety Notice letter dated December 3, 2015 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to check inventory, cease use and distribution of stock of the affected product batch and quarantine immediately.. The letter included an acknowledgment form which was to be completed and returned your MAQUET representative. For further information or support concerning this issue, contact your local MAQUET representative at [email protected]. For questions contact your local sales representative or Customer Service.
US Nationwide Distribution in the states of FL, KS and WV.
2,700 ea.