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 replacing certain oxygenator mounting brackets that are currently being used with the heater-cooler 3t as they could be a source or re-contamination with non-tuberculous mycobacteria of a clean heater-cooler 3t's water circuit.