Mentor, Ohio-based Steris’s System 1 landed in “violating device” status in December 2009, after 18 months of legal wrangling with the FDA that ended in the de facto recall of a product that hadn’t been linked to any cases of infection or injury. The federal watchdog agency had warned that Steris made significant modifications to the System 1 without seeking additional 510(k) clearance, but Steris denied in letters to customers that changes to the device merited a new application.
Ultimately the FDA ordered hospitals across the country to stop using the devices, setting a 6-month sunset on the phase-out. The safety watchdog ended up extending the deadline until August 2, 2012, by which time Steris had won initial clearance for its successor System 1e device.
Today Steris said Judge Christopher Boyko of the U.S. District Court for Northern Ohio terminated the consent decree struck in April 2010. Boyko dismissed and closed the case based on Steris’ unopposed argument that “over the past 5 years, the company was in continuous compliance with the terms of the consent decree, the Federal Food, Drug, & Cosmetic Act, and all applicable laws and regulations related to its liquid chemical sterilization products,” the company said.
The decision means it’s no longer subject to a court order on its compliance with FDA regulations, Steris said.
Steris is battling another federal agency, the FTC, over its proposed $1.9 billion merger with Synergy Health. The anti-trust regulator began reviewing the deal after it was announced in October 2014. The companies said in mid-January that the FTC had requested additional information and documentary material related to the deal, effectively extending the initial deal closing of March 31. In March the companies postponed a shareholder vote on their proposed merger in order to comply with an information request from the FTC, before extending the completion date to Dec. 31.
U.K. regulators approved the deal in February.
Last month, the company agreed to put up $175 million for Philadelphia-based General Econopak, which makes sterility maintenance, barrier protection and sterile cleanroom products. Steris also said it paid $51 million for Black Diamond Video, which makes OR integration systems.
STE shares ticked up 0.9% to $65.29 apiece in mid-day trading.