Events

Nebulisers / Nebuliser Mask ProductsUno multi-angle nebuliser (50) int 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 ConvaTec 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-01155-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-11-27
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01155-1
  • 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
    Convatec have determined that specific batches of nebuliser mask products are not meeting specification. an error in the manufacturing of a component (jet orifice) resulted in this component being unable to produce atomisation or misting of supplied medication, saline or water contained in the nebuliser unit. therefore the nebuliser mask will not deliver the expected therapy to the patient.
  • 조치
    The sponsor ConvaTec is advising users to inspect stock and quarantine the affected units prior to their return to the sponsor/distributor. This action has been closed-out on 26/08/2016.

Device

Nebulisers / Nebuliser Mask ProductsUno multi-angle nebuliser (50) int
  • 모델명 / 제조번호(시리얼번호)
    Nebulisers / Nebuliser Mask ProductsUno multi-angle nebuliser (50) intProduct Code: 1638-00Uno Multi-angle nebuliser MP T-Piece (50) intProduct Code: 1638-01Uno Aero Mask AD MA Nebuliser 210cm (50) intProduct Code: 1651-21Uno Aero Mask Child Multi-Angle Nebuliser 210cm (1x50) intProduct Code: 1654-21Multiple Lot Numbers affectedARTG Number:160226
  • Manufacturer
    ConvaTec Australia Pty Ltd

Manufacturer

ConvaTec Australia Pty Ltd