Events

PTFE GRAFTS – ADVANT VXT, FLIXENE, FLIXENE w/IFG, ADVANTA SST with expiration between April 2017 and May 2018 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Atrium Australia - Pacific Rim Pty Limited 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-00737-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2013-07-19
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00737-1
  • 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
    Atrium medical has become aware that the label on the tab of the inner tyvek cover can adhere, to the inside wall of the outer tray. this may make it more difficult to employ the user's current technique which is to first pass the inner tray from the outer tray and then onto the sterile field. in some cases, because of the sticking of the inner tray to the outer tray, it has been reported that the inner tray must be lifted from the outer tray.
  • 조치
    Atrium medical are advising users of work around instructions to follow to prevent the issue from occurring.

Device

PTFE GRAFTS – ADVANT VXT, FLIXENE, FLIXENE w/IFG, ADVANTA SST with expiration between April 2017 ...
  • 모델명 / 제조번호(시리얼번호)
    PTFE GRAFTS – ADVANT VXT, FLIXENE, FLIXENE w/IFG, ADVANTA SST with expiration between April 2017 and May 2018Multiple catalogue and lot numbers affectedARTG Numbers: 154085, 155155, 155159, 155171, 154087, 155157, 155158, 155161, 155168, 155957, 176909, 155225, 182788
  • Manufacturer
    Atrium Australia - Pacific Rim Pty Limited

Manufacturer

Atrium Australia - Pacific Rim Pty Limited
  • Source
    DHTGA