Events

Rappel 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

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Medela Australia Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2016-RN-01069-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-08-24
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01069-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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.
  • Action
    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,...
  • Modèle / numéro de série
    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