Events

Recall of Device Recall VeinViewer

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Christie Medical Holding 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
    61420
  • Event Risk Class
    Class 2
  • Event Number
    Z-1280-2012
  • Event Initiated Date
    2012-03-14
  • Event Date Posted
    2012-03-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-10-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108034
  • 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
    Device, vein location, liquid crystal - Product Code KZA
  • Reason
    Instrument may tip over if not moved correctly.
  • Action
    Christie Medical Holdings, Inc. sent an Urgent Medical Device Correction by letter on March 14, 2012 to all affected customers. The letter identified the product, problem and actions to be taken. The letter includes "Correct Transport" and "Do Not Pull labels to be applied to the unit. Customers were instructed to immediately examine their inventory, quarantine all product subject to correction and apply the labels prior to use. A Service Bulletin is enclosed that should be kept and placed with the User Guide for future reference and a Response Form to be completed and return as soon as possible. For questions contact Technical Service at 901-721-0300.

Device

Device Recall VeinViewer
  • Model / Serial
    All codes distributed between 05/02/2006  08/31/2011
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of: Argentina, Australia, China, Brazil, Czech Republic, Canada, Germany, Denmark, Spain, Great Britain, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, South Korea, Kuwait, Mexico, Malaysia, Netherlands, Norway, Philippines, Russian Federation, Saudi Arabia, Singapore, Thailand, Turkey, Taiwan, and United Arab Emirates
  • Product Description
    VeinViewer (R) by Luminetx, Model Number VV1.0, Part No: P00399-L, Luminetx Corporation, Memphis, TN 38104 || Product Usage: || Non- invasive electronic visual aid device designed to project an image of a superficial subcutaneous vascular structures on the surface of the skin
  • Manufacturer
    Christie Medical Holding Inc

Manufacturer

Christie Medical Holding Inc
  • Manufacturer Address
    Christie Medical Holding Inc, 1256 Union Ave, Memphis TN 38104
  • Source
    USFDA