FDA Recall
Terminated
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.
Recall: Z-2170-2008
·
Initiated April 22, 2008
Recall
- Recall Number
- Z-2170-2008
- Event Number
- 48615
- FEI Number
- 2183870
- Product Code
- FGE
- Status
- Terminated
- Root Cause
- Employee error
- Initiated
- April 22, 2008
- Posted
- August 26, 2008
- Terminated
- December 10, 2011
- Address
- Ev3 Inc 4600 Nathan Ln N, Plymouth, MN, 55442-2890
Description
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.
Reason
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.
Action
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.
Distribution
Nationwide Distribution --- state of NJ
Quantity
1 Unit