Events

Catheter Mount 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Fisher & Paykel 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-2017-RN-01310-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-10-17
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01310-1
  • 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
    Fisher & paykel healthcare (fph) has been advised of an increased rate of split tubing cuffs in specific catheter mounts. a split tubing cuff on the catheter mount may potentially cause a leak.To date, fph has not received any reports of adverse events however there is the potential that a leak could lead to patient hypoxaemia if undetected.
  • 조치
    Fisher & Paykel Healthcare advises customers to identify any affected lot numbers of the RT021 Catheter Mount from their inventory. Affected products should be destroyed and disposed of.

Device

Catheter Mount
  • 모델명 / 제조번호(시리얼번호)
    Catheter MountModel Number: RT021 Lot Numbers: From 2100089358 to 2100098462; and From 2100190360 to 2100241254ARTG Number: 273356
  • Manufacturer
    Fisher & Paykel Healthcare Pty Ltd

Manufacturer

Fisher & Paykel Healthcare Pty Ltd