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 potential risk has been identified with the alaris pump module model 8100. the pump module door keypad overlay can potentially separate from underlying assembly which could lead to fluid ingressess. cleaning a separated keypad or fluid spill can lead to a fluid ingress.