Events

Kii abdominal trocars 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Applied Medical 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-2017-RN-00636-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-05-19
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00636-1
  • 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
    Applied medical has identified the possibility that specific models and lots of kii abdominal trocars have insufficient sterilisation.
  • 조치
    Users are requested to return any affected product with a copy of the Recall Notification Confirmation Form to Applied Medical as per the instructions in the Customer Letter.

Device

Kii abdominal trocars
  • 모델명 / 제조번호(시리얼번호)
    Kii abdominal trocars5x55mm Kii Shielded Bladed Z-Thread Dual PackModel Number: CTB14 Lot Numbers: 1288910, 1275207, 1279542 and 1283892 5x55mm Kii Low Profile Bladed Z-Thread Dual PackModel Number: CTB23 Lot Numbers: 1281263, 1269692, 1288759 and 1271037ARTG Number: 224148
  • Manufacturer
    Applied Medical Australia Pty Ltd

Manufacturer

Applied Medical Australia Pty Ltd