Events

STERRAD Boosters and Adaptors (used in STERRAD NX steriliser and contains hydrogen peroxide sterilant) 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-01217-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2013-11-15
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01217-1
  • 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
    It has been determined that the instructions for use (ifu) for the sterrad booster and sterrad adaptor include incorrect directions for when a sterrad booster and adapter i, ii and iii is required to be used. it has also been determined that the current procedures for fitting a sterrad booster do not adequately mitigate the risk of improper seal between the scope and the booster or inadequate cleaning of the adaptor/scope interface.
  • 조치
    J&J; Medical is advising customers of the correct procedure to follow and providing the updated instructions for use (IFU) to ensure the devices are properly sterilised. A new checklist has also been developed to provide additional verification of the proper use of the STERRAD booster/adapter before and after the STERRAD cycle. This action has been closed-out on 10/02/2016.

Device

STERRAD Boosters and Adaptors (used in STERRAD NX steriliser and contains hydrogen peroxide steri...
  • 모델명 / 제조번호(시리얼번호)
    STERRAD Boosters and Adaptors (used in STERRAD NX steriliser and contains hydrogen peroxide sterilant)ARTG Number: 123602
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd

Manufacturer

Johnson & Johnson Medical Pty Ltd