| 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.