Product description
The O2Vent T is an oral appliance that 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 Adjuster Assembly (see PRA2017/15794).
Please note there is a separate recall for the O2Vent T Adjuster Assembly (see PRA2017/15794).
See a list of details to help identify the product
Reason the product is recalled
A correction to the Instructions for Use in relation to the adjustment range for titration is necessary.
The hazards to consumers
Some consumers who are currently being reviewed for optimised treatment may not fully benefit from this product if they don't make the revised adjustment.
What consumers should do
Consumers who are currently be reviewed for optimised treatment should make the following adjustment:
One full turn using the Adjustment Key is 360 degrees. This will adjust the pitch of the screw by 0.5mm resulting in a 0.5mm titration. The screw should be adjusted a maximum of 1mm per night (i.e. 2 full turns of the adjustment key).
Consumers can contact Oventus on 1300 533 159 for further information.
One full turn using the Adjustment Key is 360 degrees. This will adjust the pitch of the screw by 0.5mm resulting in a 0.5mm titration. The screw should be adjusted a maximum of 1mm per night (i.e. 2 full turns of the adjustment key).
Consumers can contact Oventus on 1300 533 159 for further information.
Details to help identify the product
Supplier running the recall
Oventus Manufacturing Pty Ltd
Where the product was sold
Nationally
Responsible regulators
Regulators are established or appointed by government. They enforce regulations and rules.
Quote PRA number 2017/15831 when contacting a regulator about this recall.
Recall and remedy questions
Contact the Therapeutic Goods Administration if you have:
- a question about the remedy being offered to you by the business that is responsible for managing this recall, or
- concerns about the way the business is managing this recall.