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.
- Company
- Teleflex Medical
- Recall Initiated
- December 3, 2015
- Posted
- August 9, 2016
- Terminated
- April 14, 2017
- Recall Number
- Z-2374-2016
- Quantity
- 2,700 ea.
- Firm Location
- Morrisville, NC
Reason for Recall
Cracks may occur at the 15mm and 22mm ISO female connector.
Distribution
US Nationwide Distribution in the states of FL, KS and WV.
Lot / Code Info
Lots 201450, 201451, 201452, 201504
Root Cause
Release of Material/Component prior to receiving test results
Action Taken
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 fieldactions@maquet.com. For questions contact your local sales representative or Customer Service.