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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Burrs in the packaging hinged trays may cause pin holes or fibre tears at or near the location of the packaging tray hinges in the tyvek pouch. there is a potential for a sterile barrier breach.