V-PRO 60 Low Temperature Sterilisation System with VAPROX HC Sterilant Distributed between 31 July 2014 and 17 August 2017 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Device Technologies Australia 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-2017-RN-01395-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-11-07
  • 사례 국가
  • 사례 출처
    DHTGA
  • 사례 출처 URL
  • 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
    Device technologies has identified a software issue where the v-pro 60 software verifies expiration date of the vaprox sterilant upon completion of the sterilisation cycle rather than prior to cycle initiation. verification of the vaprox expiration date at the end of the sterilisation cycle will allow for the completion of one cycle with expired vaprox sterilant. to date, the manufacturer steris has not received any reports of adverse events related to this issue.
  • 조치
    Device Technologies is advising users that microbial efficacy studies support a safety margin for use of the product for three days after the indicated expiry date. Users are advised to ensure the cycle printout indicates the expiration date of the Sterilant upon the completion of each cycle and change the sterilant if required. Instruments processed in a cycle with sterilant more than three days beyond its expiry date are not considered properly sterilised and should be reprocessed with a new cup of sterilant before use. Device Technologies will be performing a software update as a permanent correction.

Device

  • 모델명 / 제조번호(시리얼번호)
    V-PRO 60 Low Temperature Sterilisation System with VAPROX HC SterilantDistributed between 31 July 2014 and 17 August 2017ARTG Number: 154905
  • Manufacturer

Manufacturer