The FDA has issued a stern warning to infection control specialist Cenorin, advising the company to correct violations such as failing to notify the FDA of a correction sent to users of its medical device disinfection system.
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| Model 610 disinfection system--Courtesy of Cenorin |
The warning letter just posted on the agency's website says that Washington's Cenorin informed customers that its Model 610 disinfection system may provide a false temperature reading. The company recommended a daily procedure to monitor against the problem and later issued a software upgrade to warn of the temperature error.
In addition, the company "discovered through complaints that there was a potential risk of the system not injecting the proper amount of cleaning fluid during the wash cycle and not achieving the desired level of debris reduction." It redesigned the cleaning fluid system to address the failure.
However, Cenorin did not notify the FDA of these actions, so the modifications could not be approved by the agency.
In addition, the FDA says the firm's corrective actions meet the definition of a Class II recall, meaning exposure to the violative product "may cause temporary or medically reversible adverse health consequences." The agency posts recalls on its website to inform the public of corrective actions and problematic medical devices, or drugs.
The letter says Cenorin should "take prompt action to correct the violations addressed in this letter." It warns that "failure to promptly correct these violations may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties. Also, federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information into account when considering the award of contracts."
Failure to heed by warning letters can be self-destructive, as Germany's Maquet learned when the Department of Justice hit it with a permanent injunction, closed the company's Hudson, NH, manufacturing facility and temporarily suspended production of five devices.
- read the warning letter