Events

STERRAD 100S, STERRAD 50 and STERRAD NX Sterilisation Systems 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Johnson & Johnson Medical 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-2013-RN-01355-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2013-12-23
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01355-1
  • 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
    Asp has received customer complaints by healthcare workers reporting odours/smells potentially emanating from the sterrad systems. odours/smells may also be related to normal breakdown of the oil used in the steriliser vacuum pump on the sterrad 100s ,sterrad 50 and/or sterrad nx . the reported odours/smells do not impact sterility of the devices processed within the sterrad systems. asp is investigating this issue to determine the source of the odour/smell and will continue to perform planned maintenance in accordance with each system’s schedule.
  • 조치
    If users observe any odours/smells, Johnson and Johnson Medical is requesting them to leave the room as a precaution and discontinue the use of STERRAD Systems until they are serviced.

Device

STERRAD 100S, STERRAD 50 and STERRAD NX Sterilisation Systems
  • 모델명 / 제조번호(시리얼번호)
    STERRAD 100S, STERRAD 50 and STERRAD NX Sterilisation SystemsARTG Number: 123603
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd

Manufacturer

Johnson & Johnson Medical Pty Ltd