Primus Biliary Stent and Delivery System. Balloon Expandable Stent and Delivery System. Rx only. Model BXB35-07-27-75
FDA device recall Z-0442-06 · posted 2006-01-25 · Terminated
Recall details
- Recalling firm
- Ev3, Inc
- Reason for recall
- A Primus device was labeled as a BXB 35 09-37-75 but contained a BXB35 07-27-75 stent.
- Action taken
- Notification was sent to ev3 Territory Managers to have them contact their customer, have them remove affected product from their shelves and place them aside. TheTerritory Manager is responsible for retreiving affected product and returning it to ev3.
- Root cause
- Other
- Status
- Terminated
- Product code
- FGE
- Quantity affected
- 18 devices
- Distribution
- AL, AZ, FL, KS, LA, MS, NC, NE, NY, TX
- Date initiated
- 2005-08-01
- Date posted
- 2006-01-25
- Date terminated
- 2006-12-31
- Location
- Plymouth, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PRIMUS STENT AND DELIVERY SYSTEM (K043243) | Ev3, Inc. | 2004-12-09 |