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
Gambro has become aware of a possible defect on three lots of the gambro accessory s-660-c. the defect is a small hole at the level of the female luer connector that could potentially result in an intake of air into the bloodline. the air could subsequently reach the patient without passing through the "air blood" protective system of the dialysis machine. the small hole is not visible to the naked eye.