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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Letter is being issued due to reports of a rare sterile inflammatory response in patients undergoing procedures using the cook flexor check-flo inducer set with hydrophilic coating. letter via courier (fedex).