Sorin 1T & 3T Heater Cooler (Perfusion system) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Cellplex 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-00511-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2015-06-16
  • 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
    Sorin has become aware that the actual disinfection practices and the water maintenance that some users have been performing are not always conducted according to our instructions for use. without vigilant performance of the disinfection and maintenance procedures per the instructions for use, organisms can multiply in a heater cooler device and potentially form biofilm.
  • 조치
    Sorin Group is providing end users with additional instructions for cases where the heater cooler has not been maintained according to the Instructions for Use. The IFU has also been updated to include the additional cleaning instructions. This action has been closed-out on 14/07/2016.

Device

  • 모델명 / 제조번호(시리얼번호)
    Sorin 1T & 3T Heater Cooler (Perfusion system)All serial numbers starting with 16SXxxxx are affectedARTG Number: 194514
  • 의료기기 분류등급
  • Manufacturer

Manufacturer