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 above due to dilator tip damage noted during internal inspection of the percutaneous sheath introducer kits. dilator tip damage has the potential to result in vessel damage. there are no reported related illnesses or injuries from the related device.