Events

Edwards Pressure Monitoring Kit & Set 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Edwards Lifesciences 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-00772-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-08-25
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00772-1
  • 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 flow restriction issue has been identified in a trifurcated iv set included in the pressure transducer kits. a restriction of the flow of iv fluid would result in either an inability to prime the system before use or difficulty in flushing the line after a blood draw. in either instance, the tubing can be exchanged for a new set. this may result in a procedural delay.
  • 조치
    Customers are advised to check their inventory and quarantine any unused affected lots. Contact Edwards Customer Service to arrange for return of any unused product and obtain information about replacement product. This action has been closed-out on 17/08/2016.

Device

Edwards Pressure Monitoring Kit & Set
  • 모델명 / 제조번호(시리얼번호)
    Edwards Pressure Monitoring Kit & Set, Model Number: PXMK2043(used on patients requiring intravascular, intracranial, or intrauterine pressure monitoring)Lot numbers: 59994210, 60001412, 60020166 & 60030868ARTG Number: 142521
  • Manufacturer
    Edwards Lifesciences Pty Ltd

Manufacturer

Edwards Lifesciences Pty Ltd