Events

Central Venous Catheter and Pressure Monitoring SetsSingle Lumen Central Venous Catheter Sets & Trays Femoral Artery Pressure Monitoring Catheter Sets & Trays Radial Artery Pressure Monitoring Catheter Sets & Trays 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 William A Cook 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-2016-RN-00052-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2016-01-14
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00052-1
  • 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
    Certain central venous catheters and pressure monitoring sets are being recalled due to an issue being identified with a manufacturing process that could result in the potential for catheter tip fracture and/or separation. potential adverse events that may occur as a result of catheter tip fracture and or separation may include loss of device function, medical intervention to retrieve a separated segment, or complications resulting from a separated tip occluding blood flow to end organs. there have been no reports of illness or injury associated with this issue.
  • 조치
    The sponsor is advising users to inspect stock and quarantine the affected units prior to their return to the sponsor.

Device

Central Venous Catheter and Pressure Monitoring SetsSingle Lumen Central Venous Catheter Sets & T...
  • 모델명 / 제조번호(시리얼번호)
    Central Venous Catheter and Pressure Monitoring SetsSingle Lumen Central Venous Catheter Sets & TraysFemoral Artery Pressure Monitoring Catheter Sets & TraysRadial Artery Pressure Monitoring Catheter Sets & TraysReference Part Numbers (RPN): C-NPMS-501J-15, C-PMS-301-FA, C-PMS-301J-FA, C-PMS-301J-PED, C-PMS-301-RA, C-PMS-400-RA, C-PMS-401-FA and C-PMS-401J-FAMultiple Lot Numbers affectedARTG Numbers: 154878 and 156190
  • Manufacturer
    William A Cook Australia Pty Ltd

Manufacturer

William A Cook Australia Pty Ltd