Events

Retiro De Equipo (Recall) de Medela breastpumps detachable wall plug component of AC Power Adaptor Supplied with:Medela Swing, Medela Swing Maxi, Medela Swing Premium, Medela Swing Essentials, Medela Freestyle, Stand-alone AC Power Adaptor (for use with Swing Maxi and Freestyle), Affected AC Power Adaptors were supplied between 2009 and 2016

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Medela 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-2016-RN-01069-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-08-24
  • 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-01069-1
  • 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
    The ac power adaptors consist of two parts, a detachable wall plug and the power adaptor itself, with cord attached. medela has received reports of the detachable wall plug component breaking into two parts, thereby potentially exposing a live metallic contact. the exposed contact may create the risk of an electric shock to the user.There are three types detachable wall plugs, with each breastpump supplied with one of the three types. not all detachable wall plugs are affected, only those without markings or a dot on the back are affected. the ac adapter component and the breastpumps themselves are not affected by this issue.
  • Acción
    Medela is advising users to stop using the AC wall plug if they have an affected detachable wall plug, and to remove the AC wall plug from the wall while the power is switched off. The breastpump may be continued to be used on battery power. Users of affected plugs should contact Medela, who will provide a replacement wall plug. Medela is advising retailers to isolate or quarantine the affected breastpumps and stand-alone AC adapter, and to stop selling these products immediately. Medela will replace the affected stock. For more details, please see https://www.tga.gov.au/alert/medela-breastpumps-detachable-wall-plug-ac-power-adapter .

Device

Medela breastpumps detachable wall plug component of AC Power Adaptor Supplied with:Medela Swing,...
  • Modelo / Serial
    Medela breastpumps detachable wall plug component of AC Power AdaptorSupplied with:Medela Swing, Product #: 030.0040Medela Swing Maxi, Product #: 040.0011Medela Swing Premium, Product #: 030.0060Medela Swing Essentials, Product #: 030.0053Medela Freestyle, Product #: 042.0014Stand-alone AC Power Adaptor (for use with Swing Maxi and Freestyle), Product #: 099.0273 Affected AC Power Adaptors were supplied between 2009 and 2016ARTG Number: 164354
  • Manufacturer
    Medela Australia Pty Ltd

Manufacturer

Medela Australia Pty Ltd