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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원인
The horizon applier product code 337111 lot 06f1515745 was etched with the incorrect product code 237111 on the device. although the device is etched with the incorrect product code the color coding of the applier for the appropriate clip cartridge is correct.