BEUDAMED
    FDA Recall Terminated

    Edwards Lifesciences Vantex Central Venous Catheter Kit with Oligon, Ref/model #: 3K20C1827, Rx only, Edwards Lifesciences LLC, Irvine, CA 96214-5686 USA

    Recall: Z-0272-04 · Initiated October 8, 2003

    Recall

    Recall Number
    Z-0272-04
    Event Number
    27515
    Firm
    Edwards Lifesciences Corporation of Puerto Rico
    FEI Number
    2648045
    Product Code
    FOZ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 8, 2003
    Posted
    December 24, 2003
    Terminated
    February 9, 2004
    Address
    Hwy # 402 North, Box 1576, Anasco, PR, 00610

    Description

    Edwards Lifesciences Vantex Central Venous Catheter Kit with Oligon, Ref/model #: 3K20C1827, Rx only, Edwards Lifesciences LLC, Irvine, CA 96214-5686 USA

    Reason

    Lot is being recalled because some of the kits contain an incorrect guidewire.

    Action

    Customers were contacted by their Edwards Sales Representatives on 10/8/03. The Sales Representatives requested that all units be returned.

    Distribution

    Distribution was to hospitals (2) in MD and DC.

    Quantity

    315 units