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Teleflex Medical recalls Servo Humidifier 163, Model 01-06-8125-8, REF 6419365 Product Usage: A heat and moisture condenser (artifical nose)
Recalled August 17, 2016 · FDA recall Z-2374-2016 · Teleflex Medical
Hazard
Cracks may occur at the 15mm and 22mm ISO female connector. · FDA Class II
Units
2,700 ea.
Sold at
US Nationwide Distribution in the states of FL, KS and WV.
Description
Cracks may occur at the 15mm and 22mm ISO female connector.
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.
Manufacturer(s)
Teleflex Medical
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →