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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During a health canada inspection conducted from april 7-16 2014 the inspector determined the 830202 automatically change over valve for gas bottles (co2) ugv 1 device to be a class ii device in comparison to the original classification of class i. the product was placed on stop sale and will be recalled and discontinued. since the commencement of the distribution of the subject device there have been no complaints nor adverse events reported.