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 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Medela Australia Pty Ltd 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    RC-2016-RN-01069-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-08-24
  • 사례 국가
  • 사례 출처
    DHTGA
  • 사례 출처 URL
  • 비고 / 경고
    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.
  • 데이터 추가 비고
  • 원인
    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.
  • 조치
    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

  • 모델명 / 제조번호(시리얼번호)
    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

Manufacturer