BEUDAMED
    FDA Enforcement Class II 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 · Reported October 10, 2012

    Enforcement

    Recall Number
    Z-0007-2013
    Event ID
    62966
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Invuity, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    October 10, 2012
    Initiation Date
    May 12, 2012
    Classification Date
    October 3, 2012
    Termination Date
    April 23, 2013
    Address
    39 Stillman St, N/A, San Francisco, CA, 94107-1309, United States

    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.

    Code Info

    Catalog numbers: 1810000, 1811273, 1811873, 1810873, 18111073 All possible lot numbers: 8Fr: 09061802, 09070201, 09070201, 09101602, 09120701, 10022602, 10030801, 10060102; 10Fr: 09061801, 09070202, 09120702, 09101603, 10022603, 10030802, 10060905, 10060904, 10060103; 12Fr: 09052901, 09061201, 09120703, 09101604, 10022604, 10030803, 10060104.

    Distribution

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

    Quantity

    197 devices