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U.S. Department of Health and Human Services

Class 2 Device Recall StarClose

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  Class 2 Device Recall StarClose see related information
Date Initiated by Firm May 06, 2009
Date Posted July 06, 2009
Recall Status1 Terminated 3 on December 21, 2011
Recall Number Z-1657-2009
Recall Event ID 52077
PMA Number P050007 
Product Classification Vascular Closure System - Product Code MGB
Product Abbott Vascular, StarClose Vascular Closure System Part Number 14677-01, for closure of femoral artery access sites after cardiovascular catheterization.
Code Information Lot Number 750406H
Recalling Firm/
Abbott Vascular-Cardiac Therapies dba Guidant Corporation
26531 Ynez Rd
Temecula CA 92591-4630
For Additional Information Contact
Manufacturer Reason
for Recall
Potential sterility issue. Internal component quarantined for possible contamination, was released for sale after going through sterilization procedure.
FDA Determined
Cause 2
Process design
Action Between May 6 and May 8, 2009, Sales Representatives visited accounts to recover the product. Recall notifications (Urgent Product Recall letters, dated May 6, 2009) were hand delivered to customers advising them Abbott Vascular is voluntarily recalling one lot of the StarClose Vascular Closure System for a potential stenlity issue discovered internally. Customers are asked to cease use of devices from this lot and work with their local account representative to review their inventory. complete the attached Recall Effectiveness Check Form and rerturn Identified products to Abbott Vascular.
Quantity in Commerce 240 units
Distribution Nationwide distribution.
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.
PMA Database PMAs with Product Code = MGB and Original Applicant = ABBOTT VASCULAR DEVICES