Events

Retiro De Equipo (Recall) de Transwarmer Infant Transport Mattress

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Ferno 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-2015-RN-00371-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-04-30
  • 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-00371-1
  • 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
    Coopersurgical has identified that there may be product with customers that have been in inventory for more than five years. some users of the transwarmer infant transport mattress may have removed individual units from the original packaging and have been using the device past the labelled and recommended expiration date.Serious burns have been reported in the past and could occur if the products are not stored under the labelled conditions or used beyond the recommended shelf life. coopersurgical has received three complaints from the field indicating that the product may activate at higher than labelled temperatures.
  • Acción
    CooperSurgical is requesting all users to review their inventory and discard or return any product that does not display a product LOT code or expiration date on each individual unit. The brands affected include CooperSurgical and NovaPlus labelled TransWarmer Infant Transport Mattress. The LOT code and expiration date can be located on the top left corner of the individual pouches. All new units will have the lot and expiry date on the individual unit packaging. This action has been closed-out on 17/05/2017.

Device

Transwarmer Infant Transport Mattress
  • Modelo / Serial
    Transwarmer Infant Transport MattressCatalogue number: 20421All batchesOrder codes: BPOD2-TRANS06 / BPOD2-NEON03ARTG number: 221364
  • Manufacturer
    Ferno Australia Pty Ltd

Manufacturer

Ferno Australia Pty Ltd