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 initiated a voluntary product field correction for the instructions for use (ifu) for the suction irrigator reusable tips. the pre-vacuum steam sterilization (wrapped method) temperature in the instructions for use (ifu part # 1000-400-100 rev. k) incorrectly listed 121 - 123c instead of the correct 132 - 133c.