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
Biliary Catheter - Product Code FGE
원인
A primus gps biliary stent system was mislabeled. the mislabeling resulted in a 8 mm diameter, 27 mm length stent being labeled as a 8 mm x 37 mm stent.
조치
The single affected consignee was visited by an ev3 representative to verify the use of the device or exchange it for an unaffected device. Information recorded on an ev3 Device Reconciliation Form.
Ev3 Primus GPS Biliary Stent System || 8 mm, 37 mm, B7, .40 mm, 5Fr, || REF BXB35-08-37-75 || Use before 2009-02 || Sterile EO || Ev3 4600 Nathan Lane North, Plymouth, MN 55442-2920 || Intended as a palliative treatment of malignant neoplasms in the biliary tree.