FDA Warns Steris Over Sterilization Device

Law360, New York (May 29, 2008, 12:00 AM EDT) -- Steris Corp. has been dealt a blow by the U.S. Food and Drug Administration, revealing Wednesday that it received a warning letter from the agency over a sterilization device for surgical instruments.

The company said in a filing with the U.S. Securities and Exchange Commission that it was handed the warning letter on May 16 regarding Steris' System 1 sterile processor and the S-20 sterilant used with the processor.

“The warning letter references a number of changes to the device that the FDA believes should be...
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