Events

Recall of Lumex

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

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
    37747
  • Event Risk Class
    Class 2
  • Event Number
    Z-0772-2007
  • Event Initiated Date
    2007-04-02
  • Event Date Posted
    2007-05-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-01-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=51451
  • 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
    Rollator - Product Code ITJ
  • Reason
    The caster bolt stem/screw may loosen over time causing the wheel to come off.
  • Action
    Graham-Field notified all of its Durable Medical Equipment (DME) dealers involved in the distribution of these products by certified US Mail on April 3, 2007. They were made aware of the need to adjust the product to lessen the risk of injury and were provided a re-work kit. The distribution of DME dealers includes the announcement of the field correction to the DME dealer, the letter to send to the end-users, rework supplies, rework instructions and proof of compliance cards. Graham-Field instructed the DME dealers to adjust any impacted products on site, as well as, any delivered by end-users, customers or other impacted third parties to the DME dealer for correction. DME dealers will be compensated for performing the corrective action. The installation of the rework kit involves the installation of lock washers and Locitite and is described in more detail in the attached rework instructions. Graham-Field does not have direct access to end user names, however it plans to reach end-users by financially supporting a certified mailing from DME dealers to their individual customers notifying them of this field correction. A follow-up 60 day certified mailing will be performed for non-responders.

Device

Lumex
  • Model / Serial
    Model numbers: RJ4300B, RJ4300D, RF4300G, RJ4300K, RJ4300R, and Imperial Model RF4400K. (Note: Models distributed after January 2007, serial numbers 120791 through 145254, are not subject to this correction)
  • Product Classification
    Physical Medicine Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    U.S. Nationwide, Costa Rica, Ecuador, El Salvador, Guatemala, and Santo Domingo
  • Product Description
    Lumex¿ Walkabout Lite Four-Wheel Rollator, Manufactured for: Graham-Field Health Products, Atlanta, Georgia 30360.
  • Manufacturer
    Graham Field Atlanta

Manufacturer

Graham Field Atlanta
  • Manufacturer Address
    Graham Field Atlanta, 2935 Northeast Pkwy, Atlanta GA 30360-2808
  • Source
    USFDA