Enforcement Report - Week of August 1, 2012
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Product Detail
| 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. |
|---|---|
| Recall Number | Z-2058-2012 |
| Classification | Class II |
| Code Info | 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. |
| Product Distributed Qty | Approx 100k sold annually x 15 years. |
| 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. |
Event Detail
| Event Id | 62520 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Westone Laboratories, Inc. |
| City | Colorado Springs |
| State | CO | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-07-13 |
| Initial Firm Notification of Consignee or Public | Press Release |
| 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. |
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