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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To inform customers that a specific product code / lot number combination may potentially have incorrect information printed on the purple retainer cap. the incorrect print specifies that the balloon should be inflated with 10ml of water. however the correct volume to inflate the balloon catheter is 75cc.