Ev3 Protege GPS Biliary Stent Systems 6 mm, 60 mm, 120cm, .35, 6Fr, OTW Ev3 4600 Nathan Lane North, Plymouth, MN 55442-2
FDA device recall Z-2169-2008 · posted 2008-08-26 · Terminated
Recall details
- Recalling firm
- Ev3, Inc
- Reason for recall
- A Protege PS Biliary stent system was mislabeled. The mislabeling resulted in a 9 mm diameter, 60 mm length stent being labeled as a 6 mm x 60 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
- Distribution
- Nationwide Distribution --- state of LA.
- 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 |
|---|---|---|
| PROTEGE GPS SELF-EXPANDING NITINOL STENT AND DELIVERY SYSTEM (K032580) | Ev3, Inc. | 2003-10-22 |