Events

Edwards Lifesciences Suction Wand (Used during cardiac surgery for the suction of excessive fluid from the pericardium) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Edwards Lifesciences 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-2013-RN-00675-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2013-07-02
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00675-1
  • 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
    During inspection of some distributed rigid suction wands (model s099), edwards discovered plastic particulate inside the sterile pouch and within the internal diameter of the rigid suction wands. the particulate ranged from 0.26 to 0.41 (6.6 to 10.4mm) in size. particulate not detected during the preparation of the device may pose a risk as it may enter into the pericardium and could cause abrasions to the surface of the heart.
  • 조치
    Customers are asked to quarantine the affected product from inventory and return all affected stock with remaining shelf life to Edwards. Customers are asked to contact Edwards customer service or sales representative about alternative suction wand product's availability.

Device

Edwards Lifesciences Suction Wand (Used during cardiac surgery for the suction of excessive fluid...
  • 모델명 / 제조번호(시리얼번호)
    Edwards Lifesciences Suction Wand (Used during cardiac surgery for the suction of excessive fluid from the pericardium)Model code: S099All lot numbers ARTG number: 154578
  • 의료기기 분류등급
    Cardiovascular Devices
  • Manufacturer
    Edwards Lifesciences Pty Ltd

Manufacturer

Edwards Lifesciences Pty Ltd