Events

ReTurnBelt wipeable 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Active Medical Supplies 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-00586-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-07-22
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00586-1
  • 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
    Handicare received two complaints stating that while demonstrating the function of returnbelt, when exposed to high load, the strap ripped at the heat welded seam. this action was undertaken prior to notifying the tga.
  • 조치
    Handicare AB requested all belts with the affected lot number to be returned. Handicare AB through Active Medical is refunding the amount paid.

Device

ReTurnBelt wipeable
  • 모델명 / 제조번호(시리얼번호)
    ReTurnBelt wipeable Article Numbers: 6133,6134,6135,6136All Belts in Lot 1402SDistributed during 2014 and until March 2015ARTG Numbner: 144735
  • Manufacturer
    Active Medical Supplies Pty Ltd

Manufacturer

Active Medical Supplies Pty Ltd