Events

Of Spiggle & Theis PTFE Ventilation Tubes 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 CoreMed 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-2014-RN-00835-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-07-31
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00835-1
  • 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
    Spiggle & theis medizintechnik gmbh internal routine checks discovered that the weld seam of the blister packaging might be incomplete in the area of the pull tab.The weld seam around the blister cavity might show a visually inconsistent blue colouring. this may impair the sterility of the product.
  • 조치
    CoreMed is advising their customers not to use the blisters where the sterile barrier appears to be impaired i.e., the weld seam of the blister packaging might be incomplete in the area of the pull tab and return them to CoreMed. CoreMed will replace the affected products. This action has been closed-out on 02/06/2016.

Device

Of Spiggle & Theis PTFE Ventilation Tubes
  • 모델명 / 제조번호(시리얼번호)
    Of Spiggle & Theis PTFE Ventilation TubesArticle Numbers: 104100, 104115, 104125Multiple batch numbers affectedARTG Number: 182921
  • Manufacturer
    CoreMed Pty Ltd

Manufacturer

CoreMed Pty Ltd