STERIS Corp. (NYSE: STE) has settled with the Food and Drug Administration, addressing the “violating device” status of the company’s System 1 liquid chemical sterilizer and fleshing out a transition ...
MENTOR, Ohio — STERIS Corp. seems to have turned a corner in its disagreement with the U.S. Food and Drug Administration about what customers should do with 23,000 System 1 sterilization units ...
The Food and Drug Administration is warning medical facilities to stop using the Steris System 1 Processor because the product has been significantly modified and the FDA has not approved the modified ...
After further consideration, the Food and Drug Administration (FDA) has extended the deadline to 18 months for hospitals to transition away from using the Steris System 1® (SS1) processor. Previously, ...
Healthcare facilities now have 18 months to fully transition to an alternative reprocessing device from the Steris System 1 processor, according to news release from the U.S. Food and Drug ...
Steris Corp. has reacted strongly to a Food and Drug Administration (FDA) recommendation that hospitals consider alternatives to a popular Steris sterilizing product. In a safety notice published last ...
CENTER VALLEY, Pa.--(BUSINESS WIRE)-- Aesculap, Inc. is pleased to announce that the SterilContainer S product line has been cleared by the United States Food and Drug Administration (FDA), (510(k) ...
MENTOR, Ohio--(BUSINESS WIRE)-- STERIS Corporation (NYSE: STE) today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the STERIS SYSTEM 1E ® Liquid Chemical ...
December 4, 2009 — The STERIS System 1 Processor (SS1), used in surgical and endoscopy suites for sterilizing medical instruments and devices, has been modified and is not approved for use, the US ...