Events

BARRIER Easywarm (Active Self Warming Blanket) and BARRIER Easywarm+ (Flexible Active Self Warming Blanket) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Molnlycke Health Care 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-01087-1
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2015-11-13
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01087-1
  • 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
    The affected blankets have a shelf life of 3 years but testing has indicated that blankets that are more than two years old, do not warm to the specified level of 10 hours.
  • 조치
    Molnlycke Healthcare is informing customers to inspect their current stock. BARRIER Easywarm/Easywarm+ Products which are less than 2 years old (expiry date minus 1 year) can be used normally up until the 2 year mark. In the event that the customer has any BARRIER Easywarm/Easywarm+ products which are over 2 years old but less than 3 years, the customer is to contact the local Mölnlycke Sales Manager to arrange either a full refund or a replacement at no extra cost. This action has been closed-out on 31/08/2016.

Device

BARRIER Easywarm (Active Self Warming Blanket) and BARRIER Easywarm+ (Flexible Active Self Warmin...
  • 모델명 / 제조번호(시리얼번호)
    BARRIER Easywarm (Active Self Warming Blanket) and BARRIER Easywarm+ (Flexible Active Self Warming Blanket) ARTG Number: 198120
  • Manufacturer
    Molnlycke Health Care Pty Ltd

Manufacturer

Molnlycke Health Care Pty Ltd