Recall Z-0575-2007 ยท DYB Introducer, Catheter
Abbott Vascular, Inc.
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
| Date | Mar 8, 2007 (initiated Jan 31, 2007) |
| Status | Terminated |
| Reason | Premature release of the vessel locator wings, which stabilize the device prior to clip deployment, will result in no hemostasis. |
| Root cause | 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 | 97,952 units |
| Distribution | Worldwide distribution, including USA, Puerto Rico, and 410 other countries. There were no shipments to Canada and Mexico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060902 | STARCLOSE INTRODUCER SET MODEL- 1002 Abbott Vascular, Inc., Jul 7, 2006 |