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
This recall has been terminated (originally issued March 8, 2007).
- Company
- Abbott Vascular, Inc.
- Recall Initiated
- January 31, 2007
- Posted
- March 8, 2007
- Terminated
- February 26, 2008
- Recall Number
- Z-0575-2007
- Quantity
- 97,952 units
- Firm Location
- Redwood City, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Premature release of the vessel locator wings, which stabilize the device prior to clip deployment, will result in no hemostasis.
Distribution
Worldwide distribution, including USA, Puerto Rico, and 410 other countries. There were no shipments to Canada and Mexico.
Lot / Code Info
Lot Numbers starting from 43034-6H to 47139-6H
Root Cause
Other
Action Taken
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.