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Oto-Ease ear lubricant

Urgent medical device recall

The product may have bacterial contamination and appear either runny or cloudy.

Published
Level:Consumer
Class:II
Reference:RC-2011-RN-01010-3
Date agreed:18 October 2011
Product:Oto-Ease® Ear Lubricant (supplied between 01 May 2011 - 07 October 2011)
Sponsor:Ultra Suppliers Pty Ltd
Contact:0404 081 494 or sales@ultrasuppliers.com.au
Reason:The product may have bacterial contamination and appear either runny or cloudy.
  • The Therapeutic Goods Administration has been advised that some bottles of Oto-Ease® Ear Lubricant (also called Oto-Ease® Earmold and Hearing Aid Lubricant) may be contaminated and are being recalled.
  • If you have a bottle of Oto-Ease® Ear Lubricant supplied between 01 May 2011 - 07 October 2011, discontinue using it immediately.
  • This product may be 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.
  • Contact your doctor if you have been using this product and have any concerns.
  • Consumers can return the product to the place of purchase for a refund. For further information please contact Ultra Suppliers Pty Ltd on 0404 081 494 or sales@ultrasuppliers.com.au.
  • Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the TGA.
  • Information on how to report a suspected problem with a medicine or medical device to the TGA can be found at 'Reporting Problems'.

Classification system:

Class I defects are potentially life-threatening or could cause a serious risk to health.

Class II defects could cause illness or mistreatment, but are not Class I.

Class III defects may not pose a significant hazard to health, but withdrawal may be initiated for other reasons.

Class I & II recalls are considered to be safety related recalls.

Product types