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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A weld failure of the titanium intrauterine probe at the cervical stop stopper was observed. changes have been made to the manufacturing and inspection process to mitigate potential for separation of the intrauterine probe for lots j14 and higher.