Retiro De Equipo (Recall) de LipiFlow System Activator (used as part of the LipiFlow Thermal Pulsation 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
  • ID del evento
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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 a labelling issue with specific lots of the lipiflow system activator. the activator package label, box label, package insert and the lipiflow system instructions for use (ifu) specify 10°c to 40°c for the activator storage temperature. this specification was with the intent that the activator would be stored in a temperature-controlled room environment (with heat and air conditioning) with allowance for occasional fluctuations between 10°c and 40°c.Upon review, it has been determined that the labelled storage temperature should be consistent with the temperature conditions tested for the entire duration of the product shelf-life. accordingly, the storage temperature on the activator package and box labels has been revised to specify, “store at controlled room temperature.” the revised package insert and the lipiflow system ifu specify: “store the activator at controlled room temperature (20°c to 25°c) with short-term (< 72 hours) excursions permitted between 5°c and 38°c.”.
  • Acción
    Emergo is requesting customers to read the enclosed "Summary of Important Labelling Changes for the LipiFlow System" and discontinue use of stock that are not in temperature-controlled environments (without heat and air conditioning). Customers are further requested to contact their local distributor to organise for replacement stock. This action has been closed-out on 23/06/2017.


  • Modelo / Serial
    LipiFlow System Activator (used as part of the LipiFlow Thermal Pulsation System)Model Number: LFD-1000All Lots distributed between 1 Jan 2014 to 3 Feb 2017Expiry Date: Jul 2017 to Feb 2021ARTG Number: 189438
  • Manufacturer