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 thermal fuse does not have sufficient physical contact with the heater block causing the fuse to blow unnecessarily creating an alarm (false positive situation). when this alarm occurs it causes the sterilizer to cancel the sterilization cycle.