Steris Corp. said Tuesday it has submitted a new liquid chemical sterilization system to the U.S. Food and Drug Administration.
Regulators sent the company a warning letter in May regarding its System 1 Sterile Processing System. A statement from Steris said the new system includes technology updates and "addresses the changes referenced by the FDA in the warning letter."
The statement doesn't elaborate on the warning letter.
Steris said it will continue to support the existing System 1 and will work with customers to transition to the new product once it receives FDA approval.
System 1 is a low-temperature liquid sterilizer for heat-sensitive medical instruments like flexible endoscopes.
Steris shares fell 2.1 percent, or 49 cents, to $23.47 in Tuesday morning trading.
via yahoo
Regulators sent the company a warning letter in May regarding its System 1 Sterile Processing System. A statement from Steris said the new system includes technology updates and "addresses the changes referenced by the FDA in the warning letter."
The statement doesn't elaborate on the warning letter.
Steris said it will continue to support the existing System 1 and will work with customers to transition to the new product once it receives FDA approval.
System 1 is a low-temperature liquid sterilizer for heat-sensitive medical instruments like flexible endoscopes.
Steris shares fell 2.1 percent, or 49 cents, to $23.47 in Tuesday morning trading.
via yahoo
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