BEUDAMED
    FDA Recall Terminated

    Edwards Lifesciences-Swan-Ganz,Thermodilution Venous Infusion Port (VIP) Catheter with AMC Thromboshield (An Antimicrobial*Heparin Coating), REF:831HF75

    Recall: Z-0338-2007 · Initiated November 27, 2006

    Recall

    Recall Number
    Z-0338-2007
    Event Number
    36934
    Firm
    Edwards Lifesciences Technology SARL
    FEI Number
    2648045
    Product Code
    DYG
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 27, 2006
    Posted
    January 5, 2007
    Terminated
    January 23, 2012
    Address
    Hwy # 402 North, Km 1.4, International Industrial Park Anasco, PR, 00610-1576

    Description

    Edwards Lifesciences-Swan-Ganz,Thermodilution Venous Infusion Port (VIP) Catheter with AMC Thromboshield (An Antimicrobial*Heparin Coating), REF:831HF75

    Reason

    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)

    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.

    Distribution

    Worldwide Distribution ----USA and countries of Columbia and Venezuela.

    Quantity

    1,110 units