U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
데이터 추가 비고
Stents, Drains And Dilators For The Biliary Ducts - Product Code FGE
원인
A primus device was labeled as a bxb 35 09-37-75 but contained a bxb35 07-27-75 stent.
조치
Notification was sent to ev3 Territory Managers to have them contact their customer, have them remove affected product from their shelves and place them aside. TheTerritory Manager is responsible for retreiving affected product and returning it to ev3.