BEUDAMED
    FDA Enforcement Class III Terminated

    RELIEVA FLEX Sinus Guide Catheter F-70. Catalog number GC070RF. Product Usage - Sinus Catheter - Intended to provide a means to access the sinus space for diagnostic and therapeutic procedures. .

    Recall: Z-1740-2015 · Reported June 17, 2015

    Enforcement

    Recall Number
    Z-1740-2015
    Event ID
    71232
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Acclarent, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 17, 2015
    Initiation Date
    April 28, 2015
    Classification Date
    June 9, 2015
    Termination Date
    June 10, 2015
    Address
    1525B Obrien Dr, N/A, Menlo Park, CA, 94025-1463, United States

    Description

    RELIEVA FLEX Sinus Guide Catheter F-70. Catalog number GC070RF. Product Usage - Sinus Catheter - Intended to provide a means to access the sinus space for diagnostic and therapeutic procedures. .

    Reason

    Acclarent determined that one single RELIEVA FLEX Sinus Guide Catheter was distributed past it's expiry date.

    Code Info

    Catalog number GC070RF, Lot 120709i-cm, Expiry 7/31/2014.

    Distribution

    US in the state of Texas

    Quantity

    986