Events

Lifemed Urinary Drainage Bag with Pump 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-2014-RN-01058-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-10-03
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01058-1
  • 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 australia has received nine (9) reports of the bard australia lifemed urinary drainage bag being incorrectly assembled with the bulb located in the wrong position. incorrect positioning of the bulb in relation to the inlet tube makes it more difficult to use to the product for its intended purpose. no reports of injuries or harm to the patient or user have been reported.
  • 조치
    Customers are advised to check all inventory locations within their institution for the affected stock and segregate these items from their inventory for returning to Bard Australia. This action has been closed-out on 01/03/2016.

Device

Lifemed Urinary Drainage Bag with Pump
  • 모델명 / 제조번호(시리얼번호)
    Lifemed Urinary Drainage Bag with PumpProduct Code: L153514Lot Number: NGXL1240ARTG Number: 163481
  • Manufacturer
    Bard Australia Pty Ltd

Manufacturer

Bard Australia Pty Ltd