Cure Sleeve (a dental barrier sleeve for curing light to prevent cross contamination) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Kerr 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-2015-RN-00173-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-03-02
  • 사례 국가
  • 사례 출처
    DHTGA
  • 사례 출처 URL
  • 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
    Kerr corporation received complaints that cases of cure sleeves labelled with part number 4513 contained inner boxes with part number 4500. there is a low risk associated with the use of this product because the smaller sleeve size is unlikely to able to be applied to the larger tips. if the product is used; there would be a remote potential for cross contamination due to the tearing of the sleeve.
  • 조치
    Kerr Corporation is contacting users to Recall affected units from the Market. This action has been closed-out on 15/07/2016.

Device

  • 모델명 / 제조번호(시리얼번호)
    Cure Sleeve (a dental barrier sleeve for curing light to prevent cross contamination)Part Numbers: 4513C or 4513-1Kit/Refill/Syringe Lot Numbers: 201403010110ARTG Number: 161520
  • Manufacturer

Manufacturer