Events

ClearLink System BURETROL Solution Set with 150ml ClearLink Burette (Ball-Valve Drip Chamber) (Administration sets for the infusion of intravenous solutions and blood) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Baxter Healthcare 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-2012-RN-00918-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2012-09-07
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00918-1
  • 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
    Baxter has received complaints for the buretrol ball-valve products with reports of air travelling below the ball-valve in the drip chamber and into the tubing. the ball-valve component is designed to prohibit the flow of air from the burette into the tubing as the burette is emptied. upon further investigation baxter has determined that the ball-valve feature may not function as expected, allowing air to flow past the valve and into the tubing at the completion of dose within the burette.
  • 조치
    Baxter is recalling all affected sets and replacing it with unaffected product codes.

Device

ClearLink System BURETROL Solution Set with 150ml ClearLink Burette (Ball-Valve Drip Chamber) (Ad...
  • 모델명 / 제조번호(시리얼번호)
    ClearLink System BURETROL Solution Set with 150ml ClearLink Burette (Ball-Valve Drip Chamber) (Administration sets for the infusion of intravenous solutions and blood)Product Code: 2C8819ARTG Number: 136505
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • Manufacturer
    Baxter Healthcare Pty Ltd

Manufacturer

Baxter Healthcare Pty Ltd