Events

STERRAD CYCLESURE 24 Biological Indicators within Validation Kits - (sterilisation process indicator) Biological Indicators within Validation Kits:STERRAD NX Validation Kit – STERRAD 100NX Validation Kit – STERRAD 100S/50 Validation Kit 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-2012-RN-00673-3
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2012-07-05
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00673-3
  • 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 manufacturer, asp, has determined that it does not have adequate data to support the entire duration of the product’s labelled shelf-life. as a result, the shelf life of sterrad cyclesure 24 biological indicator (bi) will be reduced by 9 months from the current expiry date on the product label.
  • 조치
    J&J; is asking customers to quarantine the affected lots that exceed the newly determined expiration date and return it to J&J.; Until the replacement stock is available, customers may continue to use the current inventory if it still has more than 9 month’s shelf life remaining. Product with labelled expiry date of May 2013 or later can be used.

Device

STERRAD CYCLESURE 24 Biological Indicators within Validation Kits - (sterilisation process indica...
  • 모델명 / 제조번호(시리얼번호)
    STERRAD CYCLESURE 24 Biological Indicators within Validation Kits - Product codes: 14324, 20253, 20228, 20232 (sterilisation process indicator)Biological Indicators within Validation Kits:STERRAD NX Validation Kit – Product code 20253STERRAD 100NX Validation Kit – Product code 20228STERRAD 100S/50 Validation Kit – Product code 20232Multiple lot numbersARTG number: 134121
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd

Manufacturer

Johnson & Johnson Medical Pty Ltd