Class 2 Device Recall VNUS ClosureFAST

• Date Initiated by Firm: March 06, 2007
• Date Posted: December 15, 2007
• Recall Status: Terminated on December 17, 2007
• Recall Number: Z-0132-2008
• Recall Event ID: 38381
• 510(K)Number: K061373
• Product Classification: Catheter - 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 CA 95138
• For Additional Information Contact: 408-360-7472
• Manufacturer Reason for Recall: Sterility (package integrity) Compromised: Product sterility may be compromised due to a pinhole under the pouch foldover.
• FDA Determined Cause: Package 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 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.

• 510(K) Database: 510(K)s with Product Code = GEI