Biliary Stent System (6Fr 9mm x 30mm).
FDA device recall Z-0008-05 · posted 2004-10-05 · Terminated
Recall details
- Recalling firm
- Ev3
- Reason for recall
- A customer complaint received indicated that a Protg stent, PN SERB65-09-30-120 was found in a pouch that was not properly sealed. The Protg GPS Stent System is 'double barrier' packaged and consists of a sealed inner tray in a sealed pouch. The pouch seal ensures sterility of the external surface of the inner tray. The inner tray seal containing the device was not affected.
- Action taken
- A recall notification letter dated September 01, 2004 was sent to customers. Customers are to retain product until pick up by Ev3 sales representatives.
- Root cause
- Other
- Status
- Terminated
- Product code
- FGE
- Quantity affected
- 5 systems
- Distribution
- South Carolina, North Carolina, and Texas.
- Date initiated
- 2004-09-01
- Date posted
- 2004-10-05
- Date terminated
- 2005-11-03
- 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 |
|---|---|---|
| PROTEGE GPS SELF-EXPANDING NITINOL STENT AND DELIVERY SYSTEM (K033314) | Ev3, Inc. | 2003-11-21 |