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
Intubation hoops utilized in the manufacture of the hr-im intubation head ring assembly have been produced with excess material beyond the pivot drill hole. when pivoting the intubation hoop into the down position this excess material can come in contact with mating accessories making it impossible to (a) pivot the hoop into its final downward position or (b) prevent the accessories from being fully seated into the head ring assembly.