Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
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Results of further testing performed on the hmts sterilant agent used in these sterilizers demonstrate that the expiry date of the sterilant can be extended from 1 year to 2 years. as a result the software in the hmts plasma sterilizers must be updated in order to recognize this extended time of expiry. this recall is being initiated in order for scican technicians to perform this software update. there is no safety issue related to this recall and the units can continue to be used.