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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Edwards has learned that damage to the crimper's sterile barrier pouch can occur if the crimper while still inside the pouch comes in contact with hard surfaces. this can occur once the pouch is removed from the protective unit carton.