Events

Xcela PICC with PASV Valve Technology/Kits, BioFlo PICC with Endexo and PASV Valve Technology/Kits 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Emergo Asia Pacific Pty Ltd T/a Emergo Australia 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-00036-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-01-22
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00036-1
  • 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
    Navilyst medical is recalling picc catheters that contain valve(s) manufactured prior to october 9, 2013. use of these picc catheters may have an increased incidence of hemolyzed blood samples which may require additional peripheral access or replacement of the picc catheter.Valves manufactured after this date incorporate a manufacturing specification change that reduces the incidence of hemolysis during blood sampling through the picc catheter and they are not subject to this recall action.Types of tests affected include blood chemistries such as electrolytes and blood count measurements such as hemoglobin and hematocrit as they can be altered by hemolysis.To date, no patient injuries have been reported to navilyst medical as a result of this issue.
  • 조치
    Customers are asked to inspect and quarantine affected stock for return to Navilyst Medical as per the directions in the Customer Letter. This action has been closed-out on 18/07/2016.

Device

Xcela PICC with PASV Valve Technology/Kits, BioFlo PICC with Endexo and PASV Valve Technology/Kits
  • 모델명 / 제조번호(시리얼번호)
    Xcela PICC with PASV Valve Technology/Kits, BioFlo PICC with Endexo and PASV Valve Technology/KitsMultiple lot numbersARTG numbers: 175080, 178780 & 203831
  • Manufacturer
    Emergo Asia Pacific Pty Ltd T/a Emergo Australia

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia