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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This field safety notice updates recommendations to mitigate the potential risk of nontuberculous mycobacterial (ntm) contamination of sorin heater cooler 3t devices and the potential risk of patient ntm infections. this update follows information released in the u.S. on october 13 2016.