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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An internal investigation led to the discovery of pinhole defects in the clear bottom film of the packaging of the two lead arthroscopic irrigation set (code 2c4030) for use with arthromatic plastic containers. these pinholes are not likely to be detected by the end user prior to use. pinholes could compromise the sterile barrier properties of the packaging.