PRA number
2016/15794
Published date
Product description
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).
Please note there is a separate recall for the O2Vent T Instructions for use (see PRA2017/15831).
Reasons the product is 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.
The hazards to consumers
The performance of the device and risk to patient safety is affected by the faulty adhesion of the Adjuster Assembly part.
What consumers should do
Consumers should stop using the product and return it to Oventus Manufacturing for a rework. Consumers can call Oventus on 1300 533 159 for further information.
Supplier
Oventus Pty Ltd
Where the product was sold
Nationally
Responsible regulator
Therapeutic Goods Administration is the responsible regulator for this recall.