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 customer complaint received indicated that a prot¿g¿ stent, pn serb65-09-30-120 was found in a pouch that was not properly sealed. the prot¿g¿ gps stent system is 'double barrier' packaged and consists of a sealed inner tray in a sealed pouch. the pouch seal ensures sterility of the external surface of the inner tray. the inner tray seal containing the device was not affected.
조치
A recall notification letter dated September 01, 2004 was sent to customers. Customers are to retain product until pick up by Ev3 sales representatives.