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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Select arterial line catheter and introducer kits manufactured by argon medical devices inc. contained in specific lots may exhibit a potential defect with the outer tray. the defect may or may not be noticeable to the user. the outer tray issue may compromise the sterile barrier.