FDA-Device2016-08-17Class II
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.
Teleflex Medical
Hazard
Cracks may occur at the 15mm and 22mm ISO female connector.
Sold states
US Nationwide Distribution in the states of FL, KS and WV.
Affected count
2,700 ea.
Manufactured in
3015 Carrington Mill Blvd, Morrisville, NC, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2374-2016Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief