BEUDAMED
    FDA Recall Terminated

    BriteField illuminated Suction Device; Model numbers 8Fr, 10Fr and 12Fr, Kit (included 8Fr, 10Fr and 12Fr and a sterilization tray. The Invuity Brite Field Illuminated Suction Device is intended to aspirate from the surgical site and to provide illumination from a high intensity light source.

    Recall: Z-0007-2013 · Initiated May 12, 2012

    Recall

    Recall Number
    Z-0007-2013
    Event Number
    62966
    Firm
    Invuity, Inc.
    FEI Number
    3007037347
    Product Code
    JOL
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 12, 2012
    Posted
    October 3, 2012
    Terminated
    April 23, 2013
    Address
    39 Stillman St, San Francisco, CA, 94107-1309

    Description

    BriteField illuminated Suction Device; Model numbers 8Fr, 10Fr and 12Fr, Kit (included 8Fr, 10Fr and 12Fr and a sterilization tray. The Invuity Brite Field Illuminated Suction Device is intended to aspirate from the surgical site and to provide illumination from a high intensity light source.

    Reason

    Invuity is notifying customers to return all obsolete BriteField Illuminated Suction Devices from the field. It has not been distributed since March 2011 as the next generation product was introduced at that time.

    Action

    Invuity sent E-mails to those locations thought to still be in possession of the old model of the device in July 2012. Distributors had been e-mailed in May 2012 to make sure that they had returned any of the device that was in stock. For questions regarding this recall call 415-655-2100.

    Distribution

    Nationwide Distribution including AR, GA, SC, CA, OR, UT, and WA.

    Quantity

    197 devices