IntraStent DoubleStrut LD - Balloon Expandable Biliary Stent, Sterilized EO, ev3 4600 Nathan Lane North, Plymouth, MN 55
FDA device recall Z-0829-06 · posted 2006-05-03 · Terminated
Recall details
- Recalling firm
- Ev3, Inc
- Reason for recall
- IntraStent product S15-36 (P/N 90-1341-02) lot 494428 was labeled as IntraStent product S15-26 (P/N 90-1341-001)
- Action taken
- On March 3, 2004, shipping personnel noted that IntraStent product S15-36, lot 494428, was labeled as IntraStent product S15-26. Six units from the lot were in distribution. On December 29, 2005, customers were sent a Field Action Form to record the number of used or available for return stents at their facility. The form instructs the customer to return the completed original form and any unused stents.
- Root cause
- Other
- Status
- Terminated
- Product code
- FGE
- Quantity affected
- 6 devices
- Distribution
- AR, GA, IN, MA, TN, and UT
- Date initiated
- 2005-12-29
- Date posted
- 2006-05-03
- 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 |
|---|---|---|
| INTRASTENT DOUBLESTRUT LD (K993904) | Intratherapeutics, Inc. | 2000-02-01 |