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U.S. Department of Health and Human Services

Class 2 Device Recall VNUS 7F ClosureFAST Catheter

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  Class 2 Device Recall VNUS 7F ClosureFAST Catheter see related information
Date Initiated by Firm August 08, 2007
Date Posted January 24, 2008
Recall Status1 Terminated 3 on May 22, 2008
Recall Number Z-0543-2008
Recall Event ID 45510
Product Classification Catheter - Product Code GEI
Product VNUS 7F ClosureFAST Catheter, Order # ClF7-7-100 (100 cm working length), Manufactured by VNUS Medical Technologies, Inc., 5799 Fontanoso Way, San Jose, CA 95138
Code Information Lot #s: 269157,  269653,  269937,  273326,  277761,  286201,  286565,  287746,  288012,  288336,  288984,  289027,  289757,  291483,  295539,  295786,  296215,  296218,  296974,  298602,  299406,  301347,  301352,  302596,  303252,  304271,  305063,  305550,  306673,  306823,  307368,  308780,  308782,  312677,  312735,  313529,  314828,  314829,  314829,  315084,  315381,  317485,  317827,  317889,  317972,  317979,  318124,  318259,  318556, and  318610,  
Recalling Firm/
Manufacturer		 VNUS Medical Technologies Inc
5799 Fontanoso Way
San Jose CA 95138-1015
Manufacturer Reason
for Recall		 Instructions for Use change: Instructions for Use have been changed to include a modified placement recommendation.
FDA Determined
Cause 2		 Labeling design
Action The Recalling firm is updating the Instructions For Use, training materials, and procedural guides to incorporate the treatment recommendations. The recalling firm sent an Update to customers who received the product, Important Update Regarding the Use of the VNUS ClosureFAST Catheter, dated August 6, 2007 with supplemental device instructions. Future product distribution will include the updated labeling.
Quantity in Commerce 6,221 units
Distribution Worldwide
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.
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