Events

Bard 100% Latex-Free Urinary Drainage Bag with Anti-Reflux Chamber and Bard EZ-Lok 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Bard 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-2015-RN-01095-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-11-09
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01095-1
  • 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
    Bard has identified that some devices from a specific lot of product have a potential breach of the sterile barrier packaging. this defect may put patients at an increased risk of an ascending urinary tract infection. symptoms of an infection could include fever, pain and burning sensation upon voiding.
  • 조치
    Bard is requesting users inspect their stocks and to quarantine affected units prior to return as per the instructions in the customer letter. If customers have used any affected product, monitor the relevant patients for symptoms and signs of localised and/or systemic infection. This action has been closed-out on 22/08/2016.

Device

Bard 100% Latex-Free Urinary Drainage Bag with Anti-Reflux Chamber and Bard EZ-Lok
  • 모델명 / 제조번호(시리얼번호)
    Bard 100% Latex-Free Urinary Drainage Bag with Anti-Reflux Chamber and Bard EZ-Lok Catalogue Number: 154006Lot Number: NGYJ0603ARTG Number: 195134
  • Manufacturer
    Bard Australia Pty Ltd

Manufacturer

Bard Australia Pty Ltd