Recall Z-2170-2008
Ev3, Inc · initiated April 22, 2008
Product
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.
Codes / lots: Lot 2092998
Reason for recall
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.
FDA-determined cause: Employee error
Action taken
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.
Details
- Recall number
- Z-2170-2008
- Initiated
- April 22, 2008
- Posted by FDA
- August 26, 2008
- Terminated
- December 10, 2011
- Product code
- FGE – Stents, Drains And Dilators For The Biliary Ducts
- Quantity
- 1 Unit
- Distribution
- Nationwide Distribution --- state of NJ
- Recalling firm
- Ev3, Inc, Plymouth, MN