Events

ClaveGuard Diathermy Pencil 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 ClaveGuard 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-00280-2
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-03-11
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00280-2
  • 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
    Claveguard has been advised that diathermy pencils manufactured under batch number 181214sy have an issue with the quality of the ink used for the sterility check mark, which may compromise the ability to clearly discern the colour change. as a precautionary measure, claveguard is recalling the affected batch.
  • 조치
    The sponsor ClaveGuard advises customers to discontinue use of any remaining stock of the affected batch prior to their quarantine. The sponsor will arrange for the replacement and recovery of the affected units. This action has been closed-out on 16/02/2017.

Device

ClaveGuard Diathermy Pencil
  • 모델명 / 제조번호(시리얼번호)
    ClaveGuard Diathermy PencilBatch Number: 18214SYARTG Number: 222138
  • Manufacturer
    ClaveGuard Pty Ltd

Manufacturer

ClaveGuard Pty Ltd
  • Source
    DHTGA