Events

Micro-Injection Pipettes for IVF procedures 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 William A Cook 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-00679-1
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2014-06-26
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00679-1
  • 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
    The listed devices are being recalled due to incorrect labelling of the product. specifically, micro-injection pipettes k-mpip-3135 have been placed into a shelf box identified as model k-mpip-3330. in addition, micro-injection pipettes k-mpip-3330 have been placed into a shelf box identified as model k-mpip-3135.
  • 조치
    Cook Medical is requesting their customers to return any remaining affected product.

Device

Micro-Injection Pipettes for IVF procedures
  • 모델명 / 제조번호(시리얼번호)
    Micro-Injection Pipettes for IVF proceduresProduct Number: K-MPIP-3135Lot Number: N118880Product Number: K-MPIP-3330Lot Number: N118800ARTG Number: 174653
  • Manufacturer
    William A Cook Australia Pty Ltd

Manufacturer

William A Cook Australia Pty Ltd