Events

Rite Aid Mini Digital Temple Touch Thermometer 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 ToLife Technologies 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-2018-RN-00195-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2018-03-06
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00195-1
  • 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 battery compartment on the thermometer is not adequately secured, allowing unintentional access to the button battery inside.In the event a young child gains access to the button batteries themselves and ingests them, they may suffer internal burns injuries, which can result in serious illness and, without appropriate medical treatment, may even result in death or permanent injury. furthermore, access to these batteries may pose a choking hazard to young children.
  • 조치
    ToLife Technologies is requesting Consumers immediately stop using the thermometer and return it to the below reply-paid address for an exchange: ToLife Technologies Reply Paid 36 PO Box 36 Welshpool, WA 6986

Device

Rite Aid Mini Digital Temple Touch Thermometer
  • 모델명 / 제조번호(시리얼번호)
    Rite Aid Mini Digital Temple Touch ThermometerLot Number: 5216ARTG Number: 171947
  • Manufacturer
    ToLife Technologies Pty Ltd

Manufacturer

ToLife Technologies Pty Ltd
  • Source
    DHTGA