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Debra Wong Yang
United States Attorney
Central District of California


United States Courthouse
312 North Spring Street
Los Angeles, California 90012
Release No. 06-021

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PRESS RELEASE

FOR IMMEDIATE RELEASE
February 16, 2006
For Information, Contact Public Affairs
Thom Mrozek (213) 894-6947

MAN INDICTED FOR SELLING TO DENTAL OFFICES ADULTERATED MEDICAL DEVICES NOT APPROVED BY F.D.A.


Los Angeles, CA - A San Dimas man surrendered this morning to federal authorities after being indicted yesterday on charges related to his sale of devices designed to clean dental equipment, even though they are not approved by the FDA and he was previously ordered to stop selling the devices.

John Bowen, 70, who runs Asepsis, Inc., was indicted yesterday on charges of 11 counts of interstate shipments of adulterated medical devices, one count of refusing to allow FDA personnel to inspect his warehouse and seven counts of contempt of court for continuing to sell his devices after being ordered to stop.

Dentists use various tools to clean and repair teeth, and those tools can become contaminated with saliva and blood. The tools must be sterilized and disinfected between uses in patients' mouths. The Food and Drug Administration must approve any medical device that is used to sterilize or disinfect dental tools. A medical device is called "adulterated" if it is marketed prior to receiving FDA approval.

After seeking and failing to obtain approval to sell his devices, Bowen marketed his devices which he often called "autoclaves" under the name SteriSafe. According to the indicment, Bowen promoted medical devices that were not approved by the FDA for sterilization uses that included use by doctor offices, AIDS patient home care, tattooists and needle exchange programs. In 1998, the government filed a lawsuit against Bowen and a federal judge issued a permanent injunction barring Bowen from manufacturing and distributing the devices until the FDA approved the products. Later that year, Bowen allegedly sent letters to his customers advising them to cover-up the "SteriSafe" label with another label saying "Asepsis Autoclave High Level Flushing Disinfector."

In 2002, the indictment alleges, Bowen began marketing a new device that he called Asepsis II and Asepsis GPA. This device has not been approved by the FDA, and Bowen has allegedly continued to sell the devices.

An indictment contains allegations that a defendant has committed a crime. Every defendant is presumed innocent until and unless proven guilty beyond a reasonable doubt.

Bowen is scheduled to make his initial court appearance this afternoon in United States District Court in Los Angeles. The first 12 counts in the indictment are misdemeanors that carry a maximum penalty of one year in federal prison. The seven charges that allege contempt of court have no maximum penalty.

This case was investigated by the Food and Drug Administration's Office of Criminal Investigation and the United States Postal Inspection Service.

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Release No. 06-021

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