Important Safety Alerts

Important Safety Alerts

TGA Class II Recall: Oto-Ease ear lubricant

21 Oct 2011

The Therapeutic Goods Administration (TGA) issued a Class II Recall which is related to Oto-Ease® Ear Lubricant (also called Oto-Ease® Earmold and Hearing Aid Lubricant). Some bottles of this lubricant may be contaminated and are being recalled. TGA advised that if you have a bottle of Oto-Ease® Ear Lubricant supplied between 01 May 2011 - 07 October 2011, discontinue using it immediately

This product maybe contaminated and could cause a local external ear infection and in rare circumstances could, in an immune compromised person, lead to a more widespread infection such as pneumonia. The TGA has assessed the likelihood of this happening to be low.

According to the Australian supplier, the product was not distributed in Hong Kong

For details, please refer to TGA website:
http://www.tga.gov.au/safety/recalls-device-oto-ease-111019.htm.

If you are in possession of the affected products, please contact your doctor or supplier for necessary actions.

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