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U.S. Department of Health and Human Services

Class 2 Device Recall StarClose

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 Class 2 Recall
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Date Posted March 08, 2007
Recall Status1 Terminated on February 26, 2008
Recall Number Z-0575-2007
Recall Event ID 37270
Premarket Notification
510(K) Number
K060902 
Product Classification Introducer, Catheter - 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, California 94063-4749
Consumer Instructions Problem is exhibited on insertion. Device, after successful implantation, should perform as intended.
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
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = DYB and Original Applicant = ABBOTT VASCULAR INC.
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