
The Food & Drug Administration gave Steris Corp. (NYSE:STE) customers an additional six months to transition from the company’s recalled System 1 sterilization device.
The agency gave the Mentor, Ohio-based company’s customers until Feb. 2, 2012 to make the change to an alternate processing system, according to a filing with the Securities & Exchange Commission.
The company said it would continue to support System 1 customers in the U.S. until that date, according to the filing.

Steris has been battling issues related to its flagship System 1 device since December 2009, when the FDA issued a safety alert warning that the device could be harmful to patients. System 1 is a liquid chemical sterilizing system used by hospitals, surgical centers and other healthcare facilities to sterilize heat-sensitive medical instruments.
The company has been working to transition customers to its new System 1E product, but another FDA-related holdup is creating problems around the replacement device.
Steris said it asked the FDA for the System 1 extension while the agency is in the midst of reviewing a 510(k) application for clearance of an accessory part to the replacement system. That part, called a biological indicator, isn’t necessary to operate the System 1E, though many customers prefer to use it. The part indicates the presence of biological materials on equipment to be sterilized.
Steris spokesman Steve Norton declined to say exactly when the company filed a 510(k) application with the FDA for the biological indicator, but said it happened after April 2010, when the company won initial clearance for System 1E.
Steris said it couldn’t make any assurances about if or when the accessory for the device might be cleared by the FDA. The company’s financial outlook, regarding revenue, System 1E shipments and earnings, remains unchanged.
Last month, Steris decreased its projection for full-year revenue, citing lower-than-anticipated shipments of the System 1E. The company shipped about 50 System 1E units through the end of last quarter and expects to ship about 1,000 this quarter, CEO Walt Rosebrough said at the time.
Rosebrough admitted that Steris was “behind schedule” in shipments of System 1E, primarily due to the FDA’s review of the accessory part.