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United States Seizes Unapproved Ozone Generators
Date:1/29/2010

FDA inspection shows devices produced under poor manufacturing condition; pose public health risk

SILVER SPRING, Md., Jan. 29 /PRNewswire-USNewswire/ -- At the request of the U.S. Food and Drug Administration, U.S. Marshals today seized 77 ozone generators, models AOS-1M and AOS-1MD, from Applied Ozone Systems of Auburn, Calif. The seized goods, which are medical devices, are valued at $75,900.

(Logo: http://www.newscom.com/cgi-bin/prnh/20090824/FDALOGO)

The FDA advises health care professionals and consumers to discontinue use of these devices, which Applied Ozone Systems claims can treat cancer, AIDS, hepatitis, herpes, and a number of other diseases and conditions. The FDA has not determined that the seized products are safe and effective in treating the diseases or conditions, and officials at Applied Ozone Systems never responded to a Dec. 21, 2009 FDA request for a voluntary recall of these ozone generators.

In addition, the agency is concerned that patients who use these AOS ozone devices as directed by the manufacturer may believe that ozone therapy serves as an appropriate treatment and as a result delay or stop conventional or prescribed effective treatment. There is also a risk of infection from potential contamination of the applicator or catheter.

The FDA inspected Applied Ozone Systems in October 2009 after obtaining an inspection warrant when the owner of the company refused to allow agency staff to inspect the facility. The agenc
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SOURCE U.S. Food and Drug Administration
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