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O2Vent T Adjuster Assembly

Official notice

10 Jan 2017

Last checked

10 Jan 2017

Risk not stated by sourceACCC

An official ACCC notice concerns O2Vent T Adjuster Assembly. The performance of the device and risk to patient safety is affected by the faulty adhesion of the Adjuster Assembly part. Published 2017-01-10.

What to do now

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.

Recall number

5745899d-7db9-4976-945a-37c2dc8e7e5a

Official notice

2017-01-10

The hazard

The performance of the device and risk to patient safety is affected by the faulty adhesion of the Adjuster Assembly part.

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Other

PRA 2017/15831

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Affected products

Product 1

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).

Risk / hazard

The performance of the device and risk to patient safety is affected by the faulty adhesion of the Adjuster Assembly part.

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

AU · Australia

Affected area 1

AU · Australia

Source & status

Source

Tier

beta

Category

HOME

Classification

Pharmacy and medical products

App estimate

unspecified

Recall details

Recall number

5745899d-7db9-4976-945a-37c2dc8e7e5a

Classification

Pharmacy and medical products

Source tier

beta

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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