Adult Circuit Tubing (Oxygen therapy delivery system) 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-2012-RN-01156-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2012-11-16
  • 사례 국가
  • 사례 출처
    DHTGA
  • 사례 출처 URL
  • 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 and paykel healthcare has become aware that one batch of tubes supplied to fisher and paykel healthcare may contain hole damage. if this hole damage is not detected during the standard leak test before patient use, it could potentially result in a gas leak in the breathing system, which may lead to a loss of pressure for the intended ventilation therapy.
  • 조치
    Fisher and Paykel is recalling affected product and is replacing it with unaffected tubing.

Device

  • 모델명 / 제조번호(시리얼번호)
    Adult Circuit Tubing (Oxygen therapy delivery system)Product Code: 900MR068Lot Numbers: 110810 & 111020ARTG Number: 129354
  • Manufacturer