ev3 Protege GPS Self-Expanding Nitinol Stent Biliary System--- Sterilization with Ethylene Oxide Gas. ev3, 4600 Nathan L
FDA device recall Z-0707-06 · posted 2006-03-18 · Terminated
Recall details
- Recalling firm
- Ev3, Inc
- Reason for recall
- Mispackaging-Protege GPS SER6-9-60-125 devices were incorrectly packaged as SER6-7-80-135. Diameter is larger than expected.
- Action taken
- An ev3 field representative will notify affected consignees in person beginning 2/27/2006. Product retrieval or use of the device will be documented using on a ''Field Action Form''. Account credit or product from an unaffected lot number will be provided.
- Root cause
- Other
- Status
- Terminated
- Product code
- FGE
- Quantity affected
- 4
- Distribution
- GA, OK and TX
- Date initiated
- 2006-02-27
- Date posted
- 2006-03-18
- Date terminated
- 2006-12-26
- 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 SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY (K011806) | Sulzer Intratherapeutics, Inc. | 2001-09-07 |