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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It was reported that the original sterilization validation did not represent the worst case scenario during validation as the tray was quite not fully loaded and did not evaluate sterilization of some of the most challenging locations in the devices such as certain lumens and stopcocks.