Events

Retiro De Equipo (Recall) de Sterile Single Use Minor Surgery Bipolar Cable, IEC-BC (Used for connecting the bipolar handpieces to the RF generator for electrosurgical procedures)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Cynosure 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-2016-RN-01267-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-09-28
  • 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-2016-RN-01267-1
  • 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
    Cynosure has identified an error in the expiration date on the label of the minor surgery bipolar cable pouch. the expiration date on the individual pouches that are provided in the 5 pack boxes does not match the expiration date on the box. the expiration date on the box is correct with a date of 2018-02, but the label on the individual pouches has a date of 2021-02. if the cable is used after that date, sterility may be compromised.
  • Acción
    Customers are advised to return any affected cables that they hold. Cynosure will be replacing affected cables upon receipt of the returned cables. This action has been closed-out on 12/05/2017.

Device

Sterile Single Use Minor Surgery Bipolar Cable, IEC-BC (Used for connecting the bipolar handpiece...
  • Modelo / Serial
    Sterile Single Use Minor Surgery Bipolar Cable, IEC-BC (Used for connecting the bipolar handpieces to the RF generator for electrosurgical procedures)Affected Lot numbers on package: 50858, 50382, 48543, 50704Affected Lot numbers on BC: 45572,48543 ARTG Number: 274615
  • Manufacturer
    Cynosure Pty Ltd

Manufacturer

Cynosure Pty Ltd