Events

Retiro De Equipo (Recall) de Device Recall LeGoo Internal Vessel Occluder 5mL

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 Genzyme Corporation, A Sanofi Company.

¿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
    65485
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2152-2013
  • Fecha de inicio del evento
    2013-06-21
  • Fecha de publicación del evento
    2013-09-03
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-08-07
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=119973
  • 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
    Occluder, internal vessel, temporary - Product Code OBC
  • Causa
    Product contains particulates (fibers).
  • Acción
    Genzyme sent a Medical Device Recall Notification letter dated June 21, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were avised to immediately discontinue use of all lots of LeGoo Endovascular Occlusion Gel and return all LeGoo and return product with the shipping label and packing slip enclosed. syringes.Complete the reply card via fax (414) 459-8791. Customer with questions were instructed to call GENCO at 877-674-2087. For questions regarding this recall call 508-270-2285.

Device

Device Recall LeGoo Internal Vessel Occluder 5mL
  • Modelo / Serial
    All lot codes
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) and internationally to Austria, Belgium, Canada, Denmark, Egypt. Europe, Finland, France, Germany, Hong Kong, Ireland, Italy, Netherlands, Poland, Saudi Arabia, Slovena, Spain, Sweden, Switzerland, The Netherlands, Turkey, and UK.
  • Descripción del producto
    LeGoo Internal Vessel Occluder 5mL || Product Number: 10-0500 || LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck.
  • Manufacturer
    Genzyme Corporation, A Sanofi Company

Manufacturer

Genzyme Corporation, A Sanofi Company
  • Dirección del fabricante
    Genzyme Corporation, A Sanofi Company, 175F New Boston St, Woburn MA 01801-6203
  • Empresa matriz del fabricante (2017)
    Sanofi
  • Source
    USFDA