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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During the assembly of the product(dyonics 25 fluid management system-patient tube set) the check valve was assembled backwards which prevents fluid from passing beyond the check valve. there is no opportunity to correct or modify the check valve assembly.