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 4
FDA device recall Z-2170-2008 · posted 2008-08-26 · Terminated
Recall details
- Recalling firm
- Ev3, Inc
- 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.
- 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.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- FGE
- Quantity affected
- 1 Unit
- Distribution
- Nationwide Distribution --- state of NJ
- Date initiated
- 2008-04-22
- Date posted
- 2008-08-26
- Date terminated
- 2011-12-10
- Location
- Plymouth, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PRIMUS STENT AND DELIVERY SYSTEM (K043243) | Ev3, Inc. | 2004-12-09 |