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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Argon medical is conducting a recall to notify customers of a potential packaging defect. the product is sealed in a pouch and the defect if present shows as a potential void or unsealed edge of the pouch. the risk is limited to any products packaged on december 15 2016. the expected rate of defect is mall and the type of defect is visible with the naked eye. the product literature warns the user to not use this product if the packaging is opened or damaged.