Events

Medical Mattresses and Mattress CoversAffected Batches: with the printed date of manufacture between 01 June 2014 and 31 January 2016 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Hill-Rom 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-2016-RN-01613-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-12-15
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01613-1
  • 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
    An issue has been identified where the defective labels may let liquid through the cover material into the foam mattress and may produce a very low risk of contamination of the mattress. the risk of infection from this defective label to a patient is very small and very unlikely.
  • 조치
    Hill-Rom is advising customers to inspect and quarantine affected stock. Replacement with unaffected goods will take place.

Device

Medical Mattresses and Mattress CoversAffected Batches: with the printed date of manufacture betw...
  • 모델명 / 제조번호(시리얼번호)
    Medical Mattresses and Mattress CoversAffected Batches: with the printed date of manufacture between 01 June 2014 and 31 January 2016Affected Products: Model NP100 including NP100W77E, NP100W85CE, NP100W85EF, NP100W90CE, NP100W90CEF, NP100W90E, NP100W90EF, NP100W90EM, NP100W90EMFModel NP150 including NP150W85E, NP150W90E, NP150W90EFARTG Number: 182238
  • Manufacturer
    Hill-Rom Pty Ltd

Manufacturer

Hill-Rom Pty Ltd