Oto Ease by Westone, labeled as a bacteria free, greaseless lubricant. Sold in 0.5 oz consumer sized semi transparent flexible plastic bottles. Product Usage: The product is used as a patient lubricant which eases insertion of earmolds and hearing instruments such as hearing aids.
Enforcement
- Recall Number
- Z-2058-2012
- Event ID
- 62520
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Westone Laboratories, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Press Release
- Report Date
- August 1, 2012
- Initiation Date
- July 13, 2012
- Classification Date
- July 20, 2012
- Termination Date
- December 14, 2012
- Address
- 2235 Executive Cir, Colorado Springs, CO, 80906-4137, United States
Description
Oto Ease by Westone, labeled as a bacteria free, greaseless lubricant. Sold in 0.5 oz consumer sized semi transparent flexible plastic bottles. Product Usage: The product is used as a patient lubricant which eases insertion of earmolds and hearing instruments such as hearing aids.
Westone is recalling all Oto Ease ear lubricant in all packaging configurations and sizes due to potential microbial contamination of the product.
Individual products are not identified with lot numbers. There may be lot numbers on the bottom of the bulk packaging of a twelve pack of individual products but the end user may not be aware of a lot number for the specific vial. No expiry is applied to the finished products.
Worlwide Distribution - US (nationwide) and to countries of: Australia, Belgium, Brazil, Canada, France, Germany, Greece, Hong Kong, Ireland, Japan, Korea, Mexico, Panama, Philippines, Russian Federation, and Singapore, Sweden, Switzerland and Thailand and United Kingdom.
Approx 100k sold annually x 15 years.