Events

Cook Beacon Tip Angiography Catheters Beacon Tip Torcon NB Advantage Catheters, Beacon Tip Royal Flush Plus High-Flow Catheters, Beacon Tip Catheters, Shuttle Select Slip-Cath, 4 FR Shuttle System Compatible 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 William A Cook 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-2016-RN-00021-2
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2016-01-06
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00021-2
  • 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
    Cook medical is initiating a recall of all lots in distribution following reports of catheter tip splits and/or separation. potential adverse events that may occur as a result of catheter tip splitting and or separation may include the loss of device function, medical intervention to retrieve the separated segment, or complications resulting from the separated tip occluding blood flow to end organs.
  • 조치
    Cook Medical is advising users to inspect and quarantine any affected lots for return to Cook Medical.

Device

Cook Beacon Tip Angiography Catheters Beacon Tip Torcon NB Advantage Catheters, Beacon Tip Royal ...
  • 모델명 / 제조번호(시리얼번호)
    Cook Beacon Tip Angiography CathetersBeacon Tip Torcon NB Advantage CathetersCatalogue Prefix: HNBR4.0, HNBR4.1 and only HNBR5.0 w/RUC SuffixBeacon Tip Royal Flush Plus High-Flow CathetersCatalogue Prefix: HNR4.0Slip-Cath Beacon Tip CathetersCatalogue Prefix: SCBR4.0, SCBR4.1, and only SCBR5.0 w/RUC SuffixShuttle Select Slip-Cath, 4 FR Shuttle System CompatibleCatalogue Prefix: SCBR4.5All Lot Numbers affectedARTG Numbers: 137861, 154909, 154911, 137865
  • 의료기기 분류등급
    Cardiovascular Devices
  • Manufacturer
    William A Cook Australia Pty Ltd

Manufacturer

William A Cook Australia Pty Ltd