Events

Fisher and Paykel Healthcare Catheter Mount 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Fisher and Paykel Healthcare 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
    22085
  • 사례 시작날짜
    2017-10-17
  • 사례 국가
    New Zealand
  • 사례 출처
    NZMMDSA
  • 사례 출처 URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • 비고 / 경고
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • 데이터 추가 비고
    Recalling Organisation: Fisher and Paykel Healthcare Ltd, 15 Maurice Paykel Place, East Tamaki, AUCKLAND 2013
  • 원인
    The manufacturer is initiating a recall due to an increased rate of split tubing cuffs in catheter mounts manufactured on specific dates., a split tubing cuff on the catheter mount may potentially cause a leak which could lead to patient hypoxemia if undetected.
  • 조치
    Product to be destroyed

Device

Fisher and Paykel Healthcare Catheter Mount
  • 모델명 / 제조번호(시리얼번호)
    Model: RT021, Affected: From Lot 2100089358 to Lot 2100098462 and from Lot 2100190360 to Lot 2100241254
  • Manufacturer
    Fisher and Paykel Healthcare Ltd

Manufacturer

Fisher and Paykel Healthcare Ltd