Events

Coban 2 Compression Layer (active support bandage) 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-2016-RN-00208-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-02-24
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00208-1
  • 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 manufacturer has advised that during printing an operator error occurred where the foil used as the primary packaging for coban 2 shows "coban 2 lite" as the product name. the compression bandage, the outer carton packaging, the corresponding instructions for use as well as the colour coding (purple for coban 2) are correct. if coban 2 is used (rather than coban 2 lite) for a patient requiring moderate compression, a reduced blood circulation in the extremity is a possible consequence. this could lead to local necrosis or complete ischemia of the lower leg.
  • 조치
    3M Australia is advising users to inspect stock and quarantine the affected batch prior to returning to 3M.

Device

Coban 2 Compression Layer (active support bandage)
  • 모델명 / 제조번호(시리얼번호)
    Coban 2 Compression Layer (active support bandage)Product Code: 20024ID Number: DH888822474Lot Number: 2018-12AQExpiry Date: Dec 2018ARTG Number: 235181
  • Manufacturer
    3M Australia Pty Ltd

Manufacturer

3M Australia Pty Ltd