Retiro De Equipo (Recall) de Cooper Surgical TransWarmer Infant Transport Mattress (Produces heat through chemical reaction)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por In Vitro Technologies 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-00801-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-07-22
  • País del evento
  • Fuente del evento
    DHTGA
  • 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
    A few of the transwarmer infant transport mattresses have been found to have self-activated. as the transwarmer only stays warm for 4 hours, if it self-activates it can no longer be used.
  • Acción
    Customers are asked to inspect and quarantine the affected stock. In Vitro Technologies will arrange the stock to be recovered. This action has been closed-out on 04/08/2016.

Device

  • Modelo / Serial
    Cooper Surgical TransWarmer Infant Transport Mattress (Produces heat through chemical reaction)Catalogue number: UNI20421Batch number: 11463 ARTG number: 218101
  • Manufacturer

Manufacturer