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U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls
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 Class 2 Recall
StarClose 		see related information
Date Posted March 08, 2007
Recall Number Z-0575-2007
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
For Additional Information Contact Denise Singleton
650-474-3193
Reason for
Recall		 Premature release of the vessel locator wings, which stabilize the device prior to clip deployment, will result in no hemostasis.
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.
 
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