Of Spiggle & Thesis PTFE Ventilation Tubes - Fluoroplastic shepard button and Fluoroplastic collar button (Tympanostomy tubes used to ventilate the middle ear subsequent to otitis media) 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-2013-RN-00888-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2013-08-20
  • 사례 국가
  • 사례 출처
    DHTGA
  • 사례 출처 URL
  • 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
    The primary packaging of the affected products could potentially have damage to the seal or seam. the sterility of the articles concerned is not guaranteed. it may not be possible for the user to identify this fault with absolute certainty.
  • 조치
    Customers are requested to quarantine the affected lots of product and organise with CoreMed for the return of any unused product.

Device

  • 모델명 / 제조번호(시리얼번호)
    Of Spiggle & Thesis PTFE Ventilation Tubes - Fluoroplastic shepard button and Fluoroplastic collar button (Tympanostomy tubes used to ventilate the middle ear subsequent to otitis media) Fluorplastic shepard button, 1.15mmRef.: 104115Lot numbers: 201208220750, 201210120800, 201211090450, 201302261000, 201301091000 and 201304121000Fluoroplastic collar button, 1.25mmRef.: 104125Lot number: 201301080700, 201302260700, A01210190500 and 201208130480ARTG Number: 182921
  • Manufacturer

Manufacturer