Device Recall BriteField illuminated Suction Device

  • Model / Serial
    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.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including AR, GA, SC, CA, OR, UT, and WA.
  • Product 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.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Invuity, Inc., 39 Stillman St, San Francisco CA 94107-1309
  • Manufacturer Parent Company (2017)
  • Source
    USFDA