Events

Retiro De Equipo (Recall) de LUTONIX 014 and 035 OTW Drug Coated PTA Dilatation Catheter

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Bard Australia Pty Ltd.

¿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
    RC-2014-RN-00153-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-02-11
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00153-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Notas adicionales en la data
  • Causa
    Lutonix has confirmed that some devices from specific lots may have been packaged in foil pouches with a defective chevron seal. this is the seal used to open the package containing the sterile balloon catheter. the potential hazard associated with a package having a defective chevron seal is loss of sterility.
  • Acción
    Customers are asked to not use or further distribute any of the affected product. Bard is advising that no special follow-up treatment or clinical care is recommended for patients who have already undergone treatment with the devices affected by this recall.

Device

LUTONIX 014 and 035 OTW Drug Coated PTA Dilatation Catheter
  • Modelo / Serial
    LUTONIX 014 and 035 OTW Drug Coated PTA Dilatation CatheterProduct Codes: 9020413500150 and 9020515250040Lot Numbers: GFXJ2800 and GFXK2769Supplied under the Special Access Scheme
  • Manufacturer
    Bard Australia Pty Ltd

Manufacturer

Bard Australia Pty Ltd