U.S. Seeks to Halt Sales of SteriSafe Devices
The U.S. attorney’s office sought an injunction Thursday to stop a Santa Ana man from selling unapproved sterilization equipment to dentists.
John Bowen, owner of Asepsis in Santa Fe Springs, has been manufacturing and distributing two types of equipment, some used by dentists to sterilize their instruments, that have not been approved by the Food and Drug Administration, said Assistant U.S. Atty. Donna J. Everett.
The U.S. attorney filed a civil lawsuit in federal court in Los Angeles seeking to prevent additional sales. The complaint alleges that federal officials have been telling Bowen for two years that he needs to apply for approval from the FDA.
Because the devices, known as the SteriSafe Handpiece Sterilizer and the SteriDot High Purity Water Ampules used in the sterilizer, have not been approved, there are no assurances that the products work or are safe, Everett said.
Inadequately cleaned dental equipment can increase the risk of transmitting disease from patient to patient, she said.
It was not known how much equipment Bowen has sold. Bowen could not be reached for comment Thursday.
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