BEUDAMED
    FDA Recall Terminated

    Edwards Lifesciences VANTEX Central Venous Catheter Set with OLIGON-Model A2720S

    Recall: Z-0318-2007 · Initiated November 2, 2006

    Recall

    Recall Number
    Z-0318-2007
    Event Number
    36817
    Firm
    Edwards Lifesciences Corporation of Puerto Rico
    FEI Number
    2648045
    Product Code
    FOZ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 2, 2006
    Posted
    December 29, 2006
    Terminated
    February 7, 2012
    Address
    Hwy # 402 North, Km 1.4, International Industrial Park Anasco, PR, 00610-1576

    Description

    Edwards Lifesciences VANTEX Central Venous Catheter Set with OLIGON-Model A2720S

    Reason

    Lack of Assurance of Sterility-Device packaging was manufactured with an incorrect lid that could compromise the sterility of the product.

    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.

    Distribution

    1 Domestic and 1 Foreign

    Quantity

    55 units domestically , 80 units internationally and 50 units are in Edwards Lifescience control