Events

Stryker Laparoscopic Manual Instruments and Accessories 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Stryker 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-2014-RN-01264-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-12-04
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01264-1
  • 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
    Stryker has identified that unacceptable validation reports were in place to support the unwrapped 10 minute, 132° (270°f) gravity steam sterilization cycle as well as the ethylene oxide (eo) sterilization cycle listed in instructions for use. this may give rise to cross infection as viable bacteria/ pathogens could be delivered to the subsequent patient. as a result the instructions for use (ifu) are being modified in a manner that these two sterilisation methods are being deleted and the remaining two options currently given (gravity wrapped & pre-vacuum wrapped methods) will remain in place.
  • 조치
    The Gravity Unwrapped sterilization cycle and the Ethylene Oxide sterilization cycle have both been deleted as sterilisation options from the Instructions for Use (IFU1000-401-070), for Laparoscopic Instruments and Accessories. New instructions for use reflecting this deletion will be circulated to customers.The Gravity Wrapped and Pre-Vacuum Wrapped sterilisation methods will remain unchanged. This ation has been closed-out on 06/07/2016.

Device

Stryker Laparoscopic Manual Instruments and Accessories
  • 모델명 / 제조번호(시리얼번호)
    Stryker Laparoscopic Manual Instruments and AccessoriesMultiple item numbers/ product descriptionsAll lotsARTG Numbers: 145845, 228398, 141250, 142780, 228395
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

Stryker Australia Pty Ltd
  • 제조사 모회사 (2017)
    Stryker
  • Source
    DHTGA