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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The affected corometrics 174 units were delivered with the incorrect fecg port label. we have identified that the corometrics 174 series products may not currently meet type cf leakage testing requirements. the products do meet testing requirement for type bf leakage limits.