Z-2058-2012 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- August 1, 2012
- Initiation Date
- July 13, 2012
- Termination Date
- December 14, 2012
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- Approx 100k sold annually x 15 years.
Product 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.
Reason for Recall
Westone is recalling all Oto Ease ear lubricant in all packaging configurations and sizes due to potential microbial contamination of the product.
Distribution Pattern
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.
Code Information
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.