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 |
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 and Original Applicant = ABBOTT VASCULAR INC.
|