Events

RPK-01 Luer Connector 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Tekmed 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-2018-RN-00251-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2018-03-28
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00251-1
  • 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
    It has been identified that there is a difficulty connecting the female luer to haemodialysis blood tubing lines, end caps and syringes which may result in blood or air leakage at the connection site. to date, there have been no reports of injury in australia as a result of this issue.
  • 조치
    TekMed is requesting customers immediately review their stock on hand for affected units and to discontinue their use and distribution. Affected product should be returned to TekMed who will issue a suitable account credit. New unaffected product is currently being manufactured.

Device

RPK-01 Luer Connector
  • 모델명 / 제조번호(시리얼번호)
    RPK-01 Luer Connector Lot Number: MCCC310Expiry Date:13-10-2021ARTG Number:145174 (Tekmed - Medcomp Long-term Implantable Haemodialysis Catheter Packs - Catheter, haemodialysis, implantable)
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • Manufacturer
    Tekmed Pty Ltd

Manufacturer

Tekmed Pty Ltd