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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Stryker endoscopy has discovered that worst-case sterilization testing was not conducted when the products were initially tested and released. the gravity sterilization parameters have been revised in the instructions for use (ifu) for the above affected products. the sterilization time has been increased in order to comply with sterility assurance requirements.