Events

Rappel de Lumex

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Graham Field Atlanta.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    37747
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0772-2007
  • Date de mise en oeuvre de l'événement
    2007-04-02
  • Date de publication de l'événement
    2007-05-05
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2010-01-12
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=51451
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Rollator - Product Code ITJ
  • Cause
    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
  • Modèle / numéro de série
    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)
  • Classification du dispositif
    Physical Medicine Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    U.S. Nationwide, Costa Rica, Ecuador, El Salvador, Guatemala, and Santo Domingo
  • Description du dispositif
    Lumex¿ Walkabout Lite Four-Wheel Rollator, Manufactured for: Graham-Field Health Products, Atlanta, Georgia 30360.
  • Manufacturer
    Graham Field Atlanta

Manufacturer

Graham Field Atlanta
  • Adresse du fabricant
    Graham Field Atlanta, 2935 Northeast Pkwy, Atlanta GA 30360-2808
  • Source
    USFDA