Events

WECK Visistat 35R Disposable Skin Stapler 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Teleflex 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-00508-1
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2017-04-20
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00508-1
  • 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
    For a single product lot, teleflex medical has identified a labelling error on the boxes which contain six individually packaged and labelled device units. some boxes are labelled as containing visistat wide devices, when they in fact contain visistat regular devices. the individual units are correctly labelled with the actual size of the device. the labelling error applies only to some units of sales boxes in the affected lot number. it is unlikely that the use of these products will result in any adverse health consequences, although it is possible there could be a delay of the procedure.
  • 조치
    Teleflex is advising users of the labelling error, and requesting that they place a copy of the customer letter detailing the issue with the affected lot.

Device

WECK Visistat 35R Disposable Skin Stapler
  • 모델명 / 제조번호(시리얼번호)
    WECK Visistat 35R Disposable Skin StaplerProduct Code: 528135Lot Number: 73H1600207ARTG Number: 126367
  • Manufacturer
    Teleflex Medical Australia Pty Ltd

Manufacturer

Teleflex Medical Australia Pty Ltd