O2Vent T Adjuster Assembly
Published 10 January 2017
Product
The O2Vent T is an oral appliance and is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnoea (OSA). The device is indicated for use during sleep to aid in the treatment of these conditions. The O2Vent T is for prescription use only. Please note there is a separate recall for the O2Vent T Instructions for use (see PRA2017/15831).
Why it was recalled
The manufacturer has determined that a correction to the Adjuster Assembly part of the O2Vent T device is necessary and must be returned for rework. The Adjuster Assembly allows adjustment of the screw and hook for appropriate titration by mandibular advancement for optimised treatment.
Hazard
The performance of the device and risk to patient safety is affected by the faulty adhesion of the Adjuster Assembly part.
Source: Product Safety Australia. RecallMatch AU provides a screening summary and is independent of the ACCC.