BEUDAMED
    FDA Recall Terminated

    Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX090603CD; Edwards Lifesciences LLC, Irvine, CA 92614.

    Recall: Z-1256-2008 · Initiated December 5, 2007

    Recall

    Recall Number
    Z-1256-2008
    Event Number
    46679
    Firm
    Edwards Lifesciences, Llc
    FEI Number
    2015691
    Product Code
    FGE
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    December 5, 2007
    Posted
    July 2, 2008
    Terminated
    January 11, 2012
    Address
    1 Edwards Way, Irvine, CA, 92614-5688

    Description

    Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX090603CD; Edwards Lifesciences LLC, Irvine, CA 92614.

    Reason

    Incorrect Expiration Date: Products were labeled with an incorrect shelf-life expiration date. Therefore, the sterility of the device may be compromised.

    Action

    Consignees were notified by an Urgent Product Recall letter sent on 12/5/07. The letter instructed users to return any affected product to the recalling firm for replacement products. The letter also advised users that the likelihood of patient complications is extremely low for products that have already been implanted in patients. Users were requested to return a confirmation form after checking the inventory for any affected products. For additional information, contact 1-949-250-3779.

    Distribution

    Nationwide Distribution

    Quantity

    Lot # FR6H0173 - 1 UNIT