Steris Corp. (NYSE:STE) customers have an extra 6 months from the FDA to transition from the company’s recalled System 1 sterilization device.
The med-tech maker will support current System 1 devices until August 2, 2012 but only in companies that provide a certificate of transition identifying the proposed installation date of replacement technology, according to an SEC 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.
The device is a liquid chemical sterilizing system used by hospitals, surgical centers and other healthcare facilities to sterilize heat-sensitive medical instruments.
The FDA granted Steris customers 6 more months in March while the federal watchdog agency reviewed a 510(k) application for clearance of an accessory part to the replacement 1E system.
Steris spokesman Steve Norton declined to say exactly when the company filed a 510(k) application with the FDA for the replacement part, a biological indicator, but said it happened after April 2010, when the company won initial clearance for System 1E.
The sterilization and decontamination technology firm has been creating jobs stateside and abroad.
Steris just opened a new European headquarters in Bordeaux, France and announced plans for "a significant investment involving a number of jobs" in Ohio, according to Cleveland.com.