Algerbrush II and Algerbrush II Accessories Algerbrush – II Rust Ring 0.5mm instrument and Rust Ring 1.0mm instrument Algerbrush – II Accessories0.5mm Burr/Chuck and 1.0mm Burr/Chuck 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 iNova Pharmaceuticals 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-2016-RN-01586-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2016-12-12
  • 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
    The operating instructions for sterilisation (version 2) were either missing or obsolete. the new operating instructions (version 3) contain specific time and temperature for sterilisation. failure to follow the new operating instructions may result in potential adverse events, including eye infections.
  • 조치
    iNova Pharmaceuticals is advising health practitioners to replace their Algerbrush-II Operating Instructions (v2) with the new instructions provided (v3) and to ensure that all relevant staff is informed of this change to the operating instructions. This action has been closed-out on 27/06/2017.

Device

  • 모델명 / 제조번호(시리얼번호)
    Algerbrush II and Algerbrush II AccessoriesAlgerbrush – II Rust Ring 0.5mm instrument and Rust Ring 1.0mm instrument Algerbrush – II Accessories0.5mm Burr/Chuck and 1.0mm Burr/Chuck ARTG Number: 93755
  • 의료기기 분류등급
  • Manufacturer

Manufacturer