Applied Ozone Systems, of Auburn, California has refused to recall a product that the U.S. Food & Drug Administration (FDA) says is an <"http://www.yourlawyer.com/practice_areas/defective_medical_devices">unapproved medical device. According to an FDA letter demanding a recall, the company allegedly claims that its AOS-1M ozone generator and AOS-1MD ozone generator devices treat cancer, AIDS, hepatitis, herpes and other infections and diseases.
According to the Associated Press, in the letter dated December 21, the FDA says the company’s products have not been evaluated for their safety and effectiveness, and under federal law, any device that claims to treat or mitigate diseases requires FDA approval or clearance. The agency said use of the unapproved medical devices could lead to health problems or death.
According to the Associated Press, the Applied Ozone Systems Web site says the AOS-1M and AOS-1MD devices can be used for colon cleansing, killing bacteria and viruses, and wound healing. One of the pages on the site claims that high colonic irrigation “kills harmful bacteria, parasites, mold yeast infections and virus.” The company states only at the end of a Web page that the generators are not sold as medical devices, the Associated Press said.
An FDA official told the Associated Press that using the device to insert ozone gas into a person’s rectum during high colonic irrigation could cause perforation, bleeding and infection, while inhaling the ozone could asthma or lung problems. Some patients may delay or stop legitimate medical therapies because of the claims made by Applied Ozone, the agency said.
The owner of Applied Ozone Systems told the Associated Press that the AOS-1M and AOS-1MD were intended for water purification, and were not being sold as medical devices. He said the FDA’s allegations were based on “misinformation and lies.” Applied Ozone Systems has not yet responded to the FDA letter.
If the company does not recall the devices in question, the FDA could take a variety of enforcement actions. According to the Associated Press, these actions include issuing an injunction to halt sales of a product, working with state authorities, fining the company or seizing its products.