| Date Initiated by Firm | January 31, 2007 |
|---|
| Date Posted | March 08, 2007 |
|---|
| Recall Status1 |
Terminated 3 on February 26, 2008 |
| Recall Number | Z-0575-2007 |
|---|
| Recall Event ID |
37270 |
| 510(K)Number | K060902 |
|---|
| Product Classification |
Vascular Closure System - Product Code DYB
|
| Product | StarClose Vascular Closure System (Clip Applier & Exchange System),
Catalog Number: 14677;
Product is manufactured by:
Abbott Vascular Inc.,
400 Saginaw Drive,
Redwood City, CA 94063 |
|---|
| Code Information |
Lot Numbers starting from 43034-6H to 47139-6H |
| FEI Number |
3000718335
|
Recalling Firm/
Manufacturer |
Abbott Vascular, Inc.
400 Saginaw Dr
Redwood City
CA
94063-4749
|
| For Additional Information Contact | Denise Singleton
650-474-3193 |
|---|
Manufacturer Reason
for Recall | Premature release of the vessel locator wings, which stabilize the device prior to clip deployment, will result in no hemostasis. |
|---|
FDA Determined
Cause 2 | Other |
|---|
| Action | On 1/31/07, the firm initiated the recall and its notification was via letters explaining the reason for the recall and requesting the product be returned to its sales rep. |
|---|
| Quantity in Commerce | 97,952 units |
|---|
| Distribution | Worldwide distribution, including USA, Puerto Rico, and 410 other countries. There were no shipments to Canada and Mexico. |
|---|
| Total Product Life Cycle | TPLC Device Report |
|---|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.
|
| 510(K) Database | 510(K)s with Product Code = DYB
|
|---|
