Events

Retiro De Equipo (Recall) de Device Recall DVX Rage Frame Safety glasses

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Wal Mart Stores, Inc.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    67740
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1810-2014
  • Fecha de inicio del evento
    2014-02-26
  • Fecha de publicación del evento
    2014-06-17
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-01-08
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126193
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Lens, spectacle, non-custom (prescription) - Product Code HQG
  • Causa
    Fifteen pairs of prescription, safety glasses did not meet required, industrial lens thickness; nor did these glasses have the osha-required manufacturer markings.
  • Acción
    Wal-Mart sent an Urgent Medical Device Recall letter dated March 12, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Actions to be taken by the Customer/User: Do not use the eyewear in any situation where safety-impact lenses are required. Replacement eyewear has been manufactured and available for the patient to pick up at the vision center where the original eyewear was purchased. Type of Action by the Company: Walmart contacted all patients on February 27 and 28. Patients were notified that their eyewear was not made at safety thickness, and that the patient should not wear the eyewear in an environment where safety thickness lenses are needed. Walmart manufactured replacement orders for all affected patients. Should you have any questions regarding this notice please call (479)277-0720

Device

Device Recall DVX Rage Frame Safety glasses
  • Modelo / Serial
    Serial Numbers: 00174-1030010,  01839-1257619,  01249-1 013988,  00036-1175608,  01052-1100006,  00359-1150914,  03283-1 055954,  00773-1 043248,  05385-1 051400,  00644-1151291,  02402-1 028575,  01903-1041038,  02294-1 024246,  03729-1 020577, 02937-1071566
  • Clasificación del producto
    Ophthalmic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US Distribution including the states of AR, AL, CA, FL, KS, LA, MN, NJ, NV,OH, TX, and SC.
  • Descripción del producto
    Safety glasses made with "Rage" frames manufactured between February 20, 2014 and February 25, 2014. The color of the frames of the recalled glasses were either white or black. || Safety Eye wear
  • Manufacturer
    Wal Mart Stores, Inc

Manufacturer

Wal Mart Stores, Inc
  • Dirección del fabricante
    Wal Mart Stores, Inc, 702 SouthWest 8th St, Bentonville AR 72716
  • Empresa matriz del fabricante (2017)
    Walmart Inc.
  • Source
    USFDA