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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Cook medical is initiating a voluntary recall because of a potential coating contamination. dsm biomedical b.V. the netherlands our supplier of the coating has recalled some of its coating material because of concerns about potential component contamination with glass particles. the reported glass particle size ranged from approximately 4 to 280 micro meter.