BEUDAMED
    FDA Recall 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 · Initiated April 28, 2015

    Recall

    Recall Number
    Z-1740-2015
    Event Number
    71232
    Firm
    Acclarent, Inc.
    FEI Number
    3005172759
    Product Code
    KAM
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    April 28, 2015
    Posted
    June 9, 2015
    Terminated
    June 10, 2015
    Address
    1525B Obrien Dr, Menlo Park, CA, 94025-1463

    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.

    Action

    Acclarent sent an Urgent Medical Device Recall letter dated May 2015 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed that if the affected catheter is still in inventory, it should be isolated and returned to Acclarent per instructions. Questions should be addressed to Gabriel Alfageme, Field Action Coordinator at 1-650-687-5398.

    Distribution

    US in the state of Texas

    Quantity

    986