Events

Coban 2 Lite 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-00207-1
  • 사례 위험등급
    Class III
  • 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-00207-1
  • 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 identified that during printing an operator error occurred where the foil used as the primary packaging for coban 2 lite shows "coban 2" as the product name. the compression bandage, the outer carton packaging, the corresponding instructions for use as well as the colour coding (green for coban 2 lite) is correct. if coban 2 lite is used by mistake for a patient requiring regular compression, the compression efficacy might not be sufficient. this would be noticed by the health care provider and corrected with the next bandage change.
  • 조치
    3M Australia is advising users to inspect stock and quarantine any affected product for return or credit. This action has been closed-out on 30/01/2017.

Device

Coban 2 Lite Compression Layer (active support bandage)
  • 모델명 / 제조번호(시리얼번호)
    Coban 2 Lite Compression Layer (active support bandage)Product Code: 20724ID Number: DH888822441Lot Number: 2017-21APExpiry Date: Dec 2017ARTG Number: 235181
  • Manufacturer
    3M Australia Pty Ltd

Manufacturer

3M Australia Pty Ltd