Events

Retiro De Equipo (Recall) de Device Recall TheraSphere

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 MDS Canada Inc. DBA MDS Nordion.

¿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
    51701
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-1325-2009
  • Fecha de inicio del evento
    2009-02-24
  • Fecha de publicación del evento
    2009-06-05
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2009-06-08
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=81031
  • 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
    microspheres radionuclide - Product Code NAW
  • Causa
    Instructions for the use of the pinch clamp that is an integral part of the therasphere administration set were not included with the distribution of the device.
  • Acción
    A User Bulletin (TS-2009-1) dated February 23, 2009 was issued to all TheraSphere user sites. The bulletin described the issue, affected units, and recommended actions for users. The bulletin instructed users on the proper use of the pinch clamp. MDS Nordion also updated the package insert with these instructions. For questions about the recall, customers in North America contact MDS Nordion Customer Service at 1-866-363-3330 and customers outside North America call 1-877-474-5999 and request Customer Service. Customers may also e-mail MDS Nordion at TheraSphere@mdsinc.com.

Device

Device Recall TheraSphere
  • Modelo / Serial
    Package Insert Number K120615-023, Rev 9.
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution -- US (states of AZ, CA, CO, FL, IL, IN, KS, MD, MI, NC, RI, OH, OR, PA, WI) and country of Canada.
  • Descripción del producto
    TheraSphere Administration Set (Part Number K125914-034). || TheraSphere is indicated for radiation treatment or as a neoadjuvant to surgery or transplantation in patients with unresectable Hepatocellular carcinoma(HCC) who can have placement of appropriately positioned hepatic arterial catheters. The device is also indicated for HCC patients with partial or branch portal vein thrombosis/occlusion.
  • Manufacturer
    MDS Canada Inc. DBA MDS Nordion

Manufacturer

MDS Canada Inc. DBA MDS Nordion
  • Dirección del fabricante
    MDS Canada Inc. DBA MDS Nordion, 447 March Road, Ottawa Canada Ontario
  • Empresa matriz del fabricante (2017)
    Nordion (Canada) Inc
  • Source
    USFDA