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 affected trays contain alcohol prep pad that are included in the scope of a field corrective initiated by triad group due to concerns about potential bacterial contamination of the prep pads. if contaminated alcohol prep pads are used there is a potential for infection to occur.