Westone Laboratories Inc. Issues Voluntary Nationwide Recall of all sizes and packaging configurations of Oto-Ease ear lubricant due to possible microbial contamination.

Date of Recall

2012-07-13

Recall Details

- July 13,2012, Westone Laboratories, Inc. is initiating a voluntary nationwide recall of all sizes and packaging configurations of Oto-Ease® ear lubricant. The products have been found through a consumer complaint and the U.S. Food and Drug Administration (FDA) sample analysis to be potentially contaminated with pathogenic bacteria and mold. Use of the product as directed for easing the insertion of custom fit ear molds and hearing instruments (including hearing aids) could result in infectious complications of the ear canal and surrounding tissues.

This product was previously recalled in October 2011 within the United States and from Australia (without FDA knowledge).

Consumers who have any size or packaging configuration should stop using the product and contact their healthcare provider. Packaging configurations include the following:

1) 0.5 oz semi transparent flexible plastic bottles with orange or semi transparent plastic screw-on dispensing caps; and

2) aluminum foil single use sample packs with red or black print writing.

The Oto-Ease unit containers are not identified with a lot number, expiration date, or UPC Code.

No injuries or illnesses have been reported to date. This recall is being conducted with the full knowledge of the FDA.

Westone Laboratories is notifying its distributors and customers through direct letter and issuance of this news release and is arranging for the disposal or return of all recalled products.1-800-357-3240 between the hours of 8:00am and 5:00pm MST or email

The products were distributed to hospitals, health professionals, and retailers nationwide and to Belgium, Greece, Canada, Thailand, Australia, Panama, Singapore, Russian Federation, Ireland, The Philippines, France, Korea, United Kingdom, Switzerland, Brazil, Japan, Germany, Mexico, Hong Kong, Sweden.

Consumers with questions may contact Westone Laboratories at at [email protected].

Any adverse reactions or quality problems experienced with the use of these products may be reported to the FDA's MedWatch Adverse Events Program either online, by regular mail or by fax.

Online: www.fda.gov/medwatch/report.htm

Regular mail: use postage-paid, pre-addressed Form FDA3500 available at www.fda.gov/MedWatch/getforms.htm

Fax: 1-800-FDA-0178

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