Date Initiated by Firm |
November 27, 2006 |
Date Posted |
January 05, 2007 |
Recall Status1 |
Terminated 3 on January 23, 2012 |
Recall Number |
Z-0338-2007 |
Recall Event ID |
36934 |
510(K)Number |
K812563
|
Product Classification |
Thermodilution VIP Catheter - Product Code DYG
|
Product |
Edwards 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 |
Action |
Edwards 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 Commerce |
1,110 units |
Distribution |
Worldwide Distribution ----USA and countries of Columbia and Venezuela. |
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 = DYG and Original Applicant = AMERICAN EDWARDS LABORATORIES
|