Events

Bard Rival PTA Catheters 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-00602-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-07-15
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00602-1
  • 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
    A portion of the affected lot contains units with an incorrect compliance card affixed to the catheter hoop inside the product pouch. specifically, the incorrect 7mm compliance card contains the incorrect balloon diameter, lengths, diameter growth (compliance), and rated burst pressure (rbp) information instead of the correct 6mm compliance card.
  • 조치
    End users are advised of the labelling issue and provided with the correct compliance card. Bard is recommending that the affected stock is isolated and that this letter is placed in a prominent positon with the isolated stock.

Device

Bard Rival PTA Catheters
  • 모델명 / 제조번호(시리얼번호)
    Bard Rival PTA Catheters Product code RV135610 lot # GFYG3726 onlyARTG#: 172107
  • Manufacturer
    Bard Australia Pty Ltd

Manufacturer

Bard Australia Pty Ltd