Events

AngioDynamics Morpheus Smart PICC CT (Central venous catheters) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Medical Specialties 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-2015-RN-00263-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-03-23
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00263-1
  • 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
    Angiodynamics, the manufacturer of morpheus smart picc ct kits is conducting a medical device recall on specific kit / lot numbers of power injectable picc catheters. based on a review of complaints, angiodynamics has determined that the power injectable picc catheters contained in these kits exhibit a higher than anticipated rate of extension tube fracture or leakage. use of the picc catheters that are subject to this recall may have an increased incidence of extension tube fractures or leakage which would require replacement of the picc catheter.
  • 조치
    Customers are advised to segregate affected stock to a secure location for return to the Medical Specialties Australia. This action has been closed-out on 1/06/2016.

Device

AngioDynamics Morpheus Smart PICC CT (Central venous catheters)
  • 모델명 / 제조번호(시리얼번호)
    AngioDynamics Morpheus Smart PICC CT (Central venous catheters)Catalogue number:12102602 Lot number: 583841 Catalogue number: 12102605Lot number: 588129Catalogue number:12102802Lot number: 601006 Catalogue number:12102813Lot number: 603510ARTG number: 204787
  • Manufacturer
    Medical Specialties Australia Pty Ltd

Manufacturer

Medical Specialties Australia Pty Ltd
  • Source
    DHTGA