Recall Z-2374-2016
Teleflex Medical · initiated December 3, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Lots 201450, 201451, 201452, 201504
Reason for recall
Cracks may occur at the 15mm and 22mm ISO female connector.
FDA-determined 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.
Details
- Recall number
- Z-2374-2016
- Initiated
- December 3, 2015
- Posted by FDA
- August 9, 2016
- Terminated
- April 14, 2017
- Product code
- BYD – Condenser, Heat And Moisture (Artificial Nose)
- Quantity
- 2,700 ea.
- Distribution
- US Nationwide Distribution in the states of FL, KS and WV.
- Recalling firm
- Teleflex Medical, Morrisville, NC