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 has identified that the affected lots may contain wire guides that were incorrectly loaded into the wire guide holder. this could lead to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.