Events

Recall of Device Recall BriteField illuminated Suction Device

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Invuity, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    62966
  • Event Risk Class
    Class 2
  • Event Number
    Z-0007-2013
  • Event Initiated Date
    2012-05-12
  • Event Date Posted
    2012-10-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-04-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112153
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Catheter and tip, suction - Product Code JOL
  • 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.

Device

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
    General Hospital and Personal Use Devices
  • 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
    Invuity, Inc.

Manufacturer

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