Events

Halyard Closed Suction Kits with Flex Connector 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Halyard 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-2018-RN-00232-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2018-04-24
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00232-1
  • 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
    Halyard australia has been made aware of overseas reports indicating certain flex connectors supplied with 'halyard closed suction with flex connector' devices may become loose or disconnect before use or during use. if disconnection occurs during use, it will result in an open respiratory circuit and interruption of patient ventilation.To date, there have been no reports of permanent patient injury as a result of this issue. no reports of disconnect have been received from australian facilities to date.
  • 조치
    Halyard is advising: - Before using the Flex Connector, evaluate its connection to the Swivel Connector of the Closed Suction adapter to ensure an adequate connection. Evaluation of the connection can be accomplished by pushing the Flex Connector onto the Swivel Connector. Users should refer to the images provided on the Customer Letter to establish whether an adequate connection has been obtained. - If a disconnection between the Flex Connector and Swivel Connector is observed during use, replace the Flex Connector with a new, sterile Flex Connector and ensure adequate connection

Device

Halyard Closed Suction Kits with Flex Connector
  • 모델명 / 제조번호(시리얼번호)
    Halyard Closed Suction Kits with Flex Connector Multiple Product TypesARTG Number: 259994(Halyard Australia - Catheter, suction, general-purpose)
  • 의료기기 분류등급
    Anesthesiology Devices
  • Manufacturer
    Halyard Australia Pty Ltd

Manufacturer

Halyard Australia Pty Ltd