BEUDAMED
    FDA Recall Terminated

    Hydrophobic HALO360 Filter that is packaged with HALO360+ Ablation Catheters Model numbers 32041-22, 32041-28, 32041-31 and 32041-34, and/or with HALO360 Sizing Balloon Model number 3441B.

    Recall: Z-0192-2009 · Initiated September 18, 2008

    Recall

    Recall Number
    Z-0192-2009
    Event Number
    49515
    Firm
    Barrx Medical, Inc.
    FEI Number
    3004904811
    Product Code
    GEI
    Status
    Terminated
    Root Cause
    Mixed-up of materials/components
    Initiated
    September 18, 2008
    Posted
    October 31, 2008
    Terminated
    April 26, 2011
    Address
    540 Oakmead Pkwy, Sunnyvale, CA, 94085-4022

    Description

    Hydrophobic HALO360 Filter that is packaged with HALO360+ Ablation Catheters Model numbers 32041-22, 32041-28, 32041-31 and 32041-34, and/or with HALO360 Sizing Balloon Model number 3441B.

    Reason

    Some units may contain the wrong filter, which does not have the proper lock and may result in a leak.

    Action

    The recall was initiated on September 18, 2008. All users and international distributors were informed by letter. The replacement filters were sent on 9/19/2008. Contact Barrx Medical, Inc. at 1-408-745-8000 for assistance.

    Distribution

    Worldwide Distribution, including USA, Austria, Australia, Belgium, Canada, France, Netherlands, Switzerland, Sweden, and UK .

    Quantity

    650 units