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 international is recalling the product referenced above because these finished good kits may contain 5 fr peel-away sheaths instead of the required 4 fr peel-away sheaths. using a 5 fr sheath instead of a 4 fr sheath could cause excessive bleeding after insertion of the device.