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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원인
Insufficient process control of the sterile barrier (blister lid) sealing process. the devices have been sealed in blister packs. pack test results from one day's production met minimum requirements of the testing regime but there was a step change in the test results indicating a change to the validated process.