Smart Site Add-on Bag Access Device 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 CareFusion Australia 316 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-01631-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-12-16
  • 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
    Reports have been received of leakages between the spike port and the drip chamber spike of the smart site add-on bag access device. separation and leakage between the spike port and the drip chamber spike may occur during infusion. to date, there have been no reports of serious injury or death in australia associated with the separation or leaks.
  • 조치
    CareFusion is advising customers to quarantine affected stock. Customer Service will then arrange for the pick-up of the affected stock and issue a replacement or an account credit.

Device

  • 모델명 / 제조번호(시리얼번호)
    Smart Site Add-on Bag Access Device Model Number: 10013365 Lot Numbers: 15055702, 15056299, 15056618, 15065645, 15075740, 15077085, 15085031, 15086107, 15095014, 15095411, 15106928, 15116928, 15126069, 15127413, 16015324, 16015607ARTG Number: 189737
  • Manufacturer

Manufacturer