Events

Fischer Cone Biopsy ExcisorSize medium (5/box) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Life Healthcare 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-2018-RN-00308-1
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2018-04-13
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00308-1
  • 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
    Finished product in lot number 212074 was identified to have been incorrectly labelled. the label incorrectly indicates the part number used for large size instead of the medium size excisor. this discrepancy does not meet the product release specifications.
  • 조치
    Customers are asked to isolate these items and place affected units in the supplied plastic bag for collection by LifeHealthcare. Replacement stock will be provided in due course. A copy of the Reply Form attached to the Customer Letter should be returned by fax or email and also be enclosed with the stock to be returned.

Device

Fischer Cone Biopsy ExcisorSize medium (5/box)
  • 모델명 / 제조번호(시리얼번호)
    Fischer Cone Biopsy ExcisorSize medium (5/box)Part Number: AP-900-151 Lot Number: 212074ARTG Number: 215626(Life Healthcare - Electrode, electrosurgical, active, foot-controlled, single use)
  • Manufacturer
    Life Healthcare Pty Ltd

Manufacturer

Life Healthcare Pty Ltd