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U.S. Department of Health and Human Services

Class 2 Device Recall Edwards Lifesciences VANTEX Central Venous Catheter Set

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  Class 2 Device Recall Edwards Lifesciences VANTEX Central Venous Catheter Set see related information
Date Initiated by Firm November 02, 2006
Date Posted December 29, 2006
Recall Status1 Terminated 3 on February 07, 2012
Recall Number Z-0318-2007
Recall Event ID 36817
510(K)Number K992532  
Product Classification Catheter Set Venous - Product Code FOZ
Product Edwards Lifesciences VANTEX Central Venous Catheter Set with OLIGON-Model A2720S
Code Information Model A2720S Lot Numbers: 946DC131, 946DC239 and 946FC460
Recalling Firm/
Edwards Lifesciences Corporation of Puerto Rico
Hwy # 402 North, Km 1.4
International Industrial Park
Anasco PR 00610-1576
Manufacturer Reason
for Recall
Lack of Assurance of Sterility-Device packaging was manufactured with an incorrect lid that could compromise the sterility of the product.
FDA Determined
Cause 2
Action Edwards initiated the recall in the US by sending a voicemail on November 2, 2006, to their sale representative requesting of all unused product from one domestic customer. The Sale representative was provided with a recall letter for the cutomer to facilitate notification. Edwards requested that either the customer or the Sale Representative provide written verification of stock and identify any unused product to be returned . This will allow Edwards to track the effectiveness of this recall. Their Eurpoe operations initiated a similar recall plan in Europe on November 2, 2006.
Quantity in Commerce 55 units domestically , 80 units internationally and 50 units are in Edwards Lifescience control
Distribution 1 Domestic and 1 Foreign
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 = FOZ and Original Applicant = BAXTER HEALTHCARE CORP.