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U.S. Department of Health and Human Services

Enforcement Report - Week of August 1, 2012

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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.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. 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. Class II Westone is recalling all Oto Ease ear lubricant in all packaging configurations and sizes due to potential microbial contamination of the product. Approx 100k sold annually x 15 years. Z-2058-2012