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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Navilyst medical has determined that the labelled expiration dating of the affected product is not fully supported by shelf life verification testing which may result in a sterility breach. use of a fluid management convenience kit where sterility has been breached may result in an increased risk of infection.