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 inner nylon sleeve may protrude from the balloon end of the silicone cannula by 0.57 to 0.76mm and could result in slightly rough edge.Follow instructions for use to adequately lubricate during insertion.