Events

Ambu AuraGain Single Use Laryngeal Mask – Sterile 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 AMBU 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-2015-RN-01240-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-12-22
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01240-1
  • 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 failure has been discovered during routine quality control at the manufacturing site. this failure may cause a small hole (approximately 0.5mm) in the pouch of the device leading to a potential compromised sterile barrier.It has been estimated that this failure mode occurs in 3% of the affected lots. ambu has not received any complaints or other market feedback on the matter, dating from when the products were marketed in 2014.
  • 조치
    AMBU is advising users to inspect stock and quarantine the affected units prior to their return to the sponsor. This action has been closed-out on 31/08/2016.

Device

Ambu AuraGain Single Use Laryngeal Mask – Sterile
  • 모델명 / 제조번호(시리얼번호)
    Ambu AuraGain Single Use Laryngeal Mask – SterileVarious Lot Numbers affectedARTG Number: 220597
  • Manufacturer
    AMBU Australia Pty Ltd

Manufacturer

AMBU Australia Pty Ltd