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
A separate accessory package is included in each hyfrecator 2000 electrosurgical unit (esu) carton. this accessory package contains 2 sterile handpiece sheaths p/n 7-796-19. from december 2 2015 to january 3 2017 the accessory packages in the hyfrecator 2000 esu cartons were packaged in error by the manufacturer with non-sterile p/n 7-796-19 handpiece sheaths in pouches that were labeled as "sterile".