Teleflex Medical recalls Servo Humidifier 163, Model 01-06-8125-8, REF 6419365 Product Usage: A heat and moisture condenser (artifical nose) is…

Recall date

December 3, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2374-2016

FDA classification

Class II

Brand / firm

Teleflex Medical

Sold / distributed

US Nationwide Distribution in the states of FL, KS and WV.

Why it was recalled

Cracks may occur at the 15mm and 22mm ISO female connector.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.