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U.S. Department of Health and Human Services

Class 2 Device Recall SwanGanz Thermodilution VIP Catheter

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 Class 2 Device Recall SwanGanz Thermodilution VIP Cathetersee related information
Date Initiated by FirmNovember 27, 2006
Date PostedJanuary 05, 2007
Recall Status1 Terminated 3 on January 23, 2012
Recall NumberZ-0338-2007
Recall Event ID 36934
510(K)NumberK812563 
Product Classification Thermodilution VIP Catheter - Product Code DYG
ProductEdwards Lifesciences-Swan-Ganz,Thermodilution Venous Infusion Port (VIP) Catheter with AMC Thromboshield (An Antimicrobial*Heparin Coating), REF:831HF75
Code Information Model Number: 831FH75 Lot Number: 246HC197 Expiration Date: Feb. 2008
Recalling Firm/
Manufacturer		 Edwards Lifesciences Technology SARL
Hwy # 402 North, Km 1.4
International Industrial Park
Anasco PR 00610-1576
Manufacturer Reason
for Recall		Misbranding-One lot of Swan-Ganz Thermodilution VIP Catheters, Model 831HF75, lot 246HC197 was labeled with different model information (831F75) on the edge label . The edge label states the model is 831F75 which incorrectly indicates that product does NOT contain an antimicrobial heparin coating. (The tray lid label correctly states the model is 831HF75, containing the heparin coating)
FDA Determined
Cause 2		Other
ActionEdwards initiated the recall in the US by sending a Customer Letter by Federal Express on November 28, 2006, along with a Q&A to their customers Service and Direct Customers to facilitate the uderstanding of the recall and the request for verification and return of all unused product.
Quantity in Commerce1,110 units
DistributionWorldwide Distribution ----USA and countries of Columbia and Venezuela.
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 = DYG
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