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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Arrow is recalling the products referenced in the attachment as there is a risk that the introducer needles packaged within the kits can be partially or fully occluded. if an occluded needle is used on a patient there is risk of delay in treatment and/or adverse event requiring medical intervention.