Events

ASP Sterrad Booster 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Advanced Sterilization Products 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
    15596
  • 사례 시작날짜
    2013-11-15
  • 사례 국가
    New Zealand
  • 사례 출처
    NZMMDSA
  • 사례 출처 URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • 비고 / 경고
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • 데이터 추가 비고
    Recalling Organisation: Johnson & Johnson Medical New Zealand Ltd, 507 Mt Wellington Highway, Mt Wellington, AUCKLAND 1060
  • 원인
    Issue 1: manufacturer has identified that the ifu for the sterrad booster and sterrad adaptor include incorrect instructions and potential consequences are failing to use the device when needed (potentially resulting in a lumen which is not sterile) or using the devices when not needed (potentially resulting in residual hydrogen peroxide left in the lumen), issue 2: the manufacturer has introduced a new verification tool that should be used with sterrad® boosters and sterrad® adaptors. this new tool is a checklist that should be printed and used to provide verification of the proper use of the sterrad® booster/adaptor before and after the sterrad® sterilization cycle.
  • 조치
    Instructions for use to be updated

Device

ASP Sterrad Booster

Manufacturer

Advanced Sterilization Products