BEUDAMED
    FDA Recall Terminated

    Inspira AIR Balloon Dilation system. Size 12 x 40 mm, Syringe volume 12 cc. Dilation of airway tree.

    Recall: Z-1864-2013 · Initiated January 11, 2013

    Recall

    Recall Number
    Z-1864-2013
    Event Number
    64625
    Firm
    Acclarent, Inc.
    FEI Number
    3005172759
    Product Code
    KTI
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    January 11, 2013
    Posted
    August 1, 2013
    Terminated
    October 25, 2013
    Address
    1525-B O'Brien Dr, Menlo Park, CA, 94025-1463

    Description

    Inspira AIR Balloon Dilation system. Size 12 x 40 mm, Syringe volume 12 cc. Dilation of airway tree.

    Reason

    Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additional language and warnings as well as to clarify some instructional steps.

    Action

    Urgent Medical Device Labeling correction letters will be sent to all consignees through a delivery system that can track delivery. After CDRH review and corrections, Acclarent began issuing customer notification on August 7, 2013

    Distribution

    Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, and Saudi Arabia.

    Quantity

    1217