Events

Klikfit CT Syringe with QFT and 75cm Extension tube 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Imaxeon 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-2016-RN-00173-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-02-11
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00173-1
  • 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
    An issue has been identified with the 75cm extension tube included with the klikfit ct syringe with qft. the coil presentation of the tube causes a pull force that could dislodge or move the connected cannula which can lead to extravasation.
  • 조치
    Imaxeon is advising users to inspect stock and quarantine any remaining units. Affected stock can be returned to Imaxeon and replaced with an alternate product.

Device

Klikfit CT Syringe with QFT and 75cm Extension tube
  • 모델명 / 제조번호(시리얼번호)
    Klikfit CT Syringe with QFT and 75cm Extension tubeCatalogue Number: ZY6022All lot numbers with an expiry date up to and including November 2020ARTG Number: 127663
  • Manufacturer
    Imaxeon Pty Ltd

Manufacturer

Imaxeon Pty Ltd
  • 제조사 모회사 (2017)
    Bayer AG
  • Source
    DHTGA