BEUDAMED
    FDA Recall Terminated

    FloTrak Elite modules FloTrak Elite P/N 1044971 FloTrak Elite P/N 1051005

    Recall: Z-3288-2011 · Initiated July 29, 2011

    Recall

    Recall Number
    Z-3288-2011
    Event Number
    59312
    Firm
    Respironics Novametrix, LLC.
    FEI Number
    1219324
    Product Code
    BZK
    Status
    Terminated
    Root Cause
    Manufacturing material removal
    Initiated
    July 29, 2011
    Posted
    September 30, 2011
    Terminated
    May 23, 2012
    Address
    5 Technology Dr, Wallingford, CT, 06492-1942

    Description

    FloTrak Elite modules FloTrak Elite P/N 1044971 FloTrak Elite P/N 1051005

    Reason

    Pressure lines maybe occluded and display incorrect tidal volumes.

    Action

    Respironics Novametrix, LLC on July 29, 2011 notified accounts via e-mail or tracked receipt, an Urgent - Medical Device Recall letter to notify customers of the issue and to instruct them on conditions for continued use. Monitors will need to be returned for functional performance testing at their facility. Customers can contact Respironics US Customer Service at 1-877-387-3311 for customers residing in the USA or +011 (203)697-6348 for International customers, if they have any questions or need additional information.

    Distribution

    Worldwide Distribution -- USA, Belgium, Canada, Chile, Columbia, Egypt, India, Italy, Spain, Saudi Arabia Thailand, GB, and Russia.

    Quantity

    41 units