Events

ArthroCare Corporation HipVac 50 Coblation Wand 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Arthrocare Australasia 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-2014-RN-01203-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-11-12
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01203-1
  • 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
    Based on internal investigation, arthrocare has confirmed that the packaging tray that houses the hipvac wand may have been damaged, which could result in a breach of the sterile barrier. this failure was discovered during final inspection.
  • 조치
    Customers are requested to Immediately discontinue use of the HipVac Wand immediately and take steps to quarantine the devices. If affected product is identified, Smith & Nephew Surgical Customer Service will be in contact with customers once the disposition form is returned, to arrange for the product to be returned and suggest alternate products. This action has been closed-out on 06/07/2016.

Device

ArthroCare Corporation HipVac 50 Coblation Wand
  • 모델명 / 제조번호(시리얼번호)
    ArthroCare Corporation HipVac 50 Coblation WandModel Number: ASHA4730-01ARTG number: 221504
  • Manufacturer
    Arthrocare Australasia Pty Ltd

Manufacturer

Arthrocare Australasia Pty Ltd