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
It was discovered during post-quarantine packaging on february 16 2016 that the ifu for the statlock sheath stabilization device for percutaneous sheath introducers (incorrect ifu) was erroneously packaged with the mega and sensation plus iab catheter kits instead of the ifu for the statlock catheter stabilization device for iab catheters (correct ifu).