Events

Retiro De Equipo (Recall) de Device Recall GlideScope GVL 2 Stat

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 Verathon 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
    76642
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1852-2017
  • Fecha de inicio del evento
    2017-03-03
  • Fecha de publicación del evento
    2017-04-18
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-08-28
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=153718
  • 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
    Laryngoscope, rigid - Product Code CCW
  • Causa
    Product labeled as gvl 2 stat (blades), lot gc32825, was physically packaged with the incorrect size device (gvl 1 stat (blades)).
  • Acción
    Verathon provided a notification letter to their Canadian distributor on March 03, 2017, and distribution of the letter to the rest-of-the-world (ROW) foreign consignees was initiated on March 10, 2017. Verathon intends to send the Urgent Medical Device Recall Glidescope GVL2 Stat letter and Customer Response Form to US consignees by March 31, 2017. Consignees should quarantine and discard any affected product on site, and fill out the attached Recall Response Form and return it to Verathon by fax to (425) 883- 2896, or email to CSNotifications@verathon.com even if they do not have any Stats (blades) subject to the recall. Consignees who have any questions about this voluntary recall, please contact Verathon representative or Verathon Customer Care at (800) 331-2313 (U.S. and Canada). If consignees located outside of the U.S. or Canada, please call (425) 867-1348. Consignees can also send email to cservice@verathon.com.

Device

Device Recall GlideScope GVL 2 Stat
  • Modelo / Serial
    Lot GC32825
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution: USA ( nationwide) and to the countries of : Canada, Chile, Mexico, Panama, Philippines, Qatar ,South Africa, and The Netherlands.
  • Descripción del producto
    It is recommended for patients with weight/size between 4-22 lbs (1.8-10 kg). || Part Number 0270-0429: GVL 2 Stat (box of 10 Stats). || Part Number 0574-0027: GVL 2 Stat (single pouched Stat). || Part Number 0270-0662: GlideScope AVL Video Baton 1-2 Kit (where one box of 10, part number 0270-0429), is added as part of the kit.
  • Manufacturer
    Verathon Inc

Manufacturer

Verathon Inc
  • Dirección del fabricante
    Verathon Inc, 20001 N Creek Pkwy, Bothell WA 98011-8218
  • Empresa matriz del fabricante (2017)
    Roper Technologies Inc
  • Source
    USFDA