Events

ProTrack Microcatheter 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Pacing Importers 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-2017-RN-01417-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-11-15
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01417-1
  • 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
    There is a chance that the affected catheters may have circumferential cracks along its length.If the cracks are present on the device, they are likely to be detected by a physician upon removal of the catheter from the packaging. the cracks may result in leakage of fluids along the catheter. there have been no adverse event reports related to this discovery.
  • 조치
    Baylis Medical is advising users to inspect stock and quarantine any unused units for return.

Device

ProTrack Microcatheter
  • 모델명 / 제조번호(시리얼번호)
    ProTrack MicrocatheterPart number: CIC35-145Lot Numbers: CIFA131113, CIFA100614, CIFA100714, CIFA241014Part number: CIC38-145Lot Numbers: CIFA161013, CIFA240614, CIFA.271113, CIFA100714, CIFA311213, CIFA180814, CIFA210214, CIFA080914, CIFA070314, CIFA.221014, CIFA270314, CIFA050115, CIFA070514, CIFA210115, CIFA210514, CIFA060215ARTG Number: 185946
  • Manufacturer
    Pacing Importers Pty Ltd

Manufacturer

Pacing Importers Pty Ltd
  • Source
    DHTGA