Events

Retiro De Equipo (Recall) de Sapheon (Covidien) VenaSeal Closure System

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

¿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-2015-RN-00376-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-05-06
  • 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-2015-RN-00376-1
  • 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
    There is the potential for a sterility breach of the outer packaging (pouch) material. a breach of the outer pouch may compromise the outside surface sterility of the sealed inner tray and does not directly affect the sterility of the device componentsthis potential for a sterile breach in the outer pouch material was discovered during standard internal packaging tests. the breach in the pouch barrier may not be detectable by visual inspection of the product. medtronic has identified possible causes for the pouch damage and has taken actions to prevent distribution of product that may be affected by this issue.
  • Acción
    Customers are asked to review their inventory, quarantine product, complete the customer confirmation certificate and return all unused product to Medtronic. This action ha been closed-out on 10/08/2016.

Device

Sapheon (Covidien) VenaSeal Closure System
  • Modelo / Serial
    Sapheon (Covidien) VenaSeal Closure SystemLot Numbers: 37399, Mnf date: 07/08/2014, Exp date: 2016-537621, Mnf date: 28/07/2014, Exp date: 2016-338407, Mnf date: 16/10/2014, Exp date: 2016-537417, Mnf date: 16/10/2014, Exp date: 2016-738756, Mnf date: 07/11/2014, Exp date: 2016-738863, Mnf date: 20/11/2014, Exp date: 2016-9ARTG Number: 194201
  • Manufacturer
    Emergo Asia Pacific Pty Ltd T/a Emergo Australia

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia