Events

70mL Centrifuge Bowl 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Haemonetics 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-2017-RN-01006-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-08-07
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01006-1
  • 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
    Haemonetics has received isolated reports that in some cases the 70ml centrifuge bowl may leak during cell salvage processing. a leaking bowl may potentially expose the operator to blood. in addition, because some amount of autologous blood intended to be returned to the patient would not be available for return, an allogenic blood transfusion may be required.
  • 조치
    Haemonetics is requesting customers: 1. Discontinue use of the affected products; and 2. Return any unused product to Haemonetics Contact your local customer service representative to coordinate the return, shipment and credit receipt of unused product.

Device

70mL Centrifuge Bowl
  • 모델명 / 제조번호(시리얼번호)
    70mL Centrifuge BowlCell Saver 5/5+ Bowl Set - 70mLProduct ID: 0291E-00Cell Saver Elite Processing Set - 70mLProduct ID: CSE-P-70Cell saver 5/5+ Bowl Set - 70mLProduct ID: 0291A-00ARTG Number: 123999
  • Manufacturer
    Haemonetics Australia Pty Ltd

Manufacturer

Haemonetics Australia Pty Ltd