Events

3M Bair Hugger Full Access Underbody Blanket 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 3M 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-2018-RN-00102-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2018-02-06
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00102-1
  • 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
    3m recently became aware that a design change to the bair hugger full access underbody blanket, models 63500, can make them more susceptible to unintended occlusion of airflow resulting in limited or partial inflation during use. the health risk associated with this issue is if blankets are only partially inflated during use in surgery, it could result in incomplete warming therapy. loss of therapy may lead to in advert perioperative hypothermia. this recall does not affect any other lots of 3m bair hugger full access underbody blanket.
  • 조치
    3M is advising users to inspect inventory and quarantine affected stock of the specified lot numbers immediately to prevent further use. 3M will be in contact with users to arrange collection of affected stock.

Device

3M Bair Hugger Full Access Underbody Blanket
  • 모델명 / 제조번호(시리얼번호)
    3M Bair Hugger Full Access Underbody BlanketModels 63500Manufactured between: 2nd October 2017 - 20th November 2017Lot Numbers: R10359, R10360, R10361, R10362, R10363, R10364, R10365, R10366Product Code: 70200791203ARTG Number: 218944
  • Manufacturer
    3M Australia Pty Ltd

Manufacturer

3M Australia Pty Ltd