Events

Retiro De Equipo (Recall) de GreenLine/D Laryngoscope Blades

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 Sun Med, 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
    50092
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-0459-2009
  • Fecha de inicio del evento
    2007-04-27
  • Fecha de publicación del evento
    2008-12-24
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-07-06
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=74711
  • 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
    Rigid laryngoscope - Product Code CCW
  • Causa
    A breakage problem of the acrylic bundles at both distal and proximal ends of the light tube for the md laryngoscope blade greenline d mac 3 has been detected. if breakage occurs during use, there is the potential for leaving approximately a one inch piece of acrylic tube in the patient's mouth.
  • Acción
    SunMed sent initial recall letter on April 27, 2007 to all distributors requesting that kits containing the MacIntosh size 3, consisting of lots number Gj and Ha be returned to facility. Replacement information was included in letter. On December 12, 2008, the firm issued a Device Recall Press Release with additional information on the potential for the tube to break during use leaving an approximate 1 inch piece of the acrylic tube in the patients mouth and subsequently requiring medical or surgical intervention to prevent serous injury to the patient. SunMed has notified its distributors and customers by certified mail and has arranged for return and replacement of all recalled products. Consumers with question may contact their distributor of the GreenLine/D or SunMed at 1-800-433-2797.

Device

GreenLine/D Laryngoscope Blades
  • Modelo / Serial
    Lots: Gj, Ha
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution
  • Descripción del producto
    Sun Med GreenLine/D Laryngoscope Blades Compatible with Fiber Optic Green System Handles, Sterile Disposable. Contents 20.
  • Manufacturer
    Sun Med, Inc.

Manufacturer

Sun Med, Inc.
  • Dirección del fabricante
    Sun Med, Inc., 12393 Belcher Road, Suite 450, Largo FL 33773-3097
  • Source
    USFDA