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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In order to further mitigate the potential risk of infection by non-tuberculous mycobacteria (see health canada ra-54106) sorin (now livanova) is taking an additional action with respect to the removal of the ice container which could be a source of contamination of the heater-cooler 3t's water circuit if the user has failed to follow the instructions for use for water maintenance and water circuit disinfection.