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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Label placed on the handle of the device indicates it is 11 fr. in diameter when in fact it is 9 fr. all packaging and other labeling indicates the correct sizing information. one lot number is being recalled in canada.