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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Some heat exchangers in these irrigation sets may have a leakage of the inner lumen which may allow the heating fluid to enter the patient fluid path or vice versa which can cause contamination of the blood.