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U.S. Department of Health and Human Services

Class 2 Device Recall StarClose

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 Class 2 Recall
StarClose
see related information
Date Posted July 06, 2009
Recall Status1 Open
Recall Number Z-1657-2009
Recall Event ID 52077
Premarket Approval
PMA Number
P050007
Product Classification Device, Hemostasis, Vascular - 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, California 92591-4630
Consumer Instructions Contact the recalling firm for information
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
DESIGN: 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 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.
PMA Database PMAs with Product Code = MGB and Applicant = ABBOTT VASCULAR DEVICES
PMAs with Product Code = MGB and Applicant = ABBOTT VASCULAR INC.
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