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U.S. Department of Health and Human Services

Class 2 Device Recall VNUS ClosureFAST

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 Class 2 Recall
VNUS ClosureFAST
see related information
Date Posted December 15, 2007
Recall Status1 Terminated on December 17, 2007
Recall Number Z-0132-2008
Recall Event ID 38381
Premarket Notification
510(K) Number
K061373 
Product Classification Electrosurgical, Cutting & Coagulation & Accessories - Product Code GEI
Product VNUS ClosureFAST catheters, Model Number: CL7-7-100, VNUS Medical Technologies, Inc., San Jose, CA 95138
Code Information Lot Numbers: 269431 and 269157
Recalling Firm/
Manufacturer
VNUS Medical Technologies Inc
5799 Fontanoso Way
San Jose, California 95138
Manufacturer Reason
for Recall
Sterility (package integrity) Compromised: Product sterility may be compromised due to a pinhole under the pouch foldover.
FDA Determined
Cause 2
DESIGN: Packaging Design/Selection
Action The recalling firm has issued customer notification letters by mail on 03/06/2007. The firm is requesting that consignees discontinue their use of the device and return recalled product . The firm will provide replacements.
Quantity in Commerce 92 units
Distribution Nationwide: Product was distributed to 18 health care providers and medical centers throughout the US in the following states: TX, UT, CA, CT, MI, NY, MI, OR, WA, VA, PA, and NJ.
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.
510(K) Database 510(K)s with Product Code = GEI and Original Applicant = VNUS MEDICAL TECHNOLOGIES, INC.
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