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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Due to the coating used on the paragon oxygenators the classification originally assigned to the oxygenators (class ii) is to be amended to a class iv. until the class iv application had been processed manufacturer would voluntarily cease sale of the paragon oxygenators. this does not affect products that have already been sold to customers.
Model Catalog: XAMOP***PMP (Lot serial: All Lots); Model Catalog: XAMOPI***MN (Lot serial: All Lots); Model Catalog: XAMOP***PP (Lot serial: All Lots); Model Catalog: XAMOP***MN (Lot serial: All Lots); Model Catalog: XCMOPI140MN (Lot serial: All Lots); Model Catalog: XAMOPI***PMP (Lot serial: All Lots); Model Catalog: XCMOP145PMP (Lot serial: All Lots); Model Catalog: XCMOP43PMP (Lot serial: All Lots); Model Catalog: XAMOPI***PP (Lot serial: All Lots)