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 over-pressure safety valves that are the subject of this recall (ln130b) are not cleared by the fda with an indication for use on the arterial side of the extracorporeal bypass circuit. these devices are cleared with an indication for use on the venous side of the extracorporeal circuit.