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U.S. Department of Health and Human Services

Class 3 Device Recall Vantex Central Venous Catheter Kit

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 Class 3 Device Recall Vantex Central Venous Catheter Kitsee related information
Date Initiated by FirmOctober 08, 2003
Date PostedDecember 24, 2003
Recall Status1 Terminated 3 on February 09, 2004
Recall NumberZ-0272-04
Recall Event ID 27515
510(K)NumberK992532 
Product Classification Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days - Product Code FOZ
ProductEdwards Lifesciences Vantex Central Venous Catheter Kit with Oligon, Ref/model #: 3K20C1827, Rx only, Edwards Lifesciences LLC, Irvine, CA 96214-5686 USA
Code Information Lot no. 973H0589 Exp. date 2/2005
FEI Number 2648045
Recalling Firm/
Manufacturer		 Edwards Lifesciences Corporation of Puerto Rico
Hwy # 402 North,Box 1576
Anasco PR 00610
For Additional Information ContactEdwin Ramos
787-826-2200
Manufacturer Reason
for Recall		Lot is being recalled because some of the kits contain an incorrect guidewire.
FDA Determined
Cause 2		Other
ActionCustomers were contacted by their Edwards Sales Representatives on 10/8/03. The Sales Representatives requested that all units be returned.
Quantity in Commerce315 units
DistributionDistribution was to hospitals (2) in MD and DC.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = FOZ
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