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.
데이터 추가 비고
원인
The product is recalled due to a labelling error on the boxes which contain ten products per box. some of the boxes labeled as 30 fr contain 32 fr. devices and the plastic pouches in which they are contained are correctly labeled with the actual size of the device.