Fenwal Transfer Pack 150ml with spike coupler (Blood collection/cell-culture container) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Aurora BioScience 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-2012-RN-01290-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2013-02-01
  • 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
    Instruction for use (ifu) manual for fenwal transfer packs 150ml with spike coupler is updated to instruct the users of the proper technique to insert/remove the coupler in order to access the bag. additionally a statement advising users that a suitable filter (170-200 microns) should be used when administering/transfusing blood products from this bag will also be added to the ifu.
  • 조치
    Aurora Bio Science is arranging for recovery of affected stock, which is to be rectified with correct Instructions for Use (IFU). Replacement stock or a credit note is to be issued for the recovered stock.

Device

  • 모델명 / 제조번호(시리얼번호)
    Fenwal Transfer Pack 150ml with spike coupler (Blood collection/cell-culture container)Catalogue / Order number: R4R2001All batch numbersARTG Number: 169160
  • Manufacturer

Manufacturer