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/ Manufacturer |
Abbott Vascular-Cardiac Therapies dba Guidant Corporation 26531 Ynez Rd Temecula CA 92591-4630
|
For Additional Information Contact |
951-914-2400
|
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
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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
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