Events

Ambu Laryngeal Mask, single-use 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Ambu AS 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
    19585
  • 사례 시작날짜
    2015-12-18
  • 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: Medxus Ltd, Unit 4, 100 Fitgerald Avenue, Christchurch 8011
  • 원인
    Potential sterility breach., 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., after identification of failure, comprehensive investigation has shown a low prevalence of up to 3% for the affected lots., manufacturer has not received any complaints or other market feedback on the matter, dating from when the products were marketed in 2014., .

Device

Ambu Laryngeal Mask, single-use
  • 모델명 / 제조번호(시리얼번호)
    Model: AMB408-300-000, Affected: 1794260, 1745425, 1724948, 1794260, 1729556, 1724950, 1732622
  • Manufacturer
    Ambu AS

Manufacturer

Ambu AS
  • 제조사 모회사 (2017)
    Ambu A/S
  • Source
    NZMMDSA