Device Recall DuraMax 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Angiodynamics Worldwide Headquarters 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
    60804
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0723-2012
  • 사례 시작날짜
    2011-12-30
  • 사례 출판 날짜
    2012-01-12
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2016-02-10
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Catheter, hemodialysis, implanted - Product Code MSD
  • 원인
    The securement cuff on the hemodialysis catheter has the potential to detach from the shaft.
  • 조치
    AngioDynamics sent an Urgent - Medical Device Recall letter dated December 30, 2011, via certified mail to all affected customers. The letter identified the affected product, the problem, and the actions to be taken. Customers were instructed to examine inventory, segregate the recalled lots and return remaining inventory to the firm. The letter states that replacement product will be shipped upon receipt and confirmation of the returned product. Customers were advised to complete the Recall Reply Form included and fax to DuraMax Hemodialysis Catheter Recall Coordinator at 518-798-1360. For questions contact your local representative or call the Customer Service Manger at ANGIODYNAMICS Customer Service at 1-800-772-6446.

Device

  • 모델명 / 제조번호(시리얼번호)
    FG Lot Numbers: 541565, 547476, 547521
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - USA (Nationwide)
  • 제품 설명
    Angiodynamics¿ DuraMax¿ 15.5F x 40cm Chronic Hemodialysis Catheter Set (with Cuff 35cm from Tip) --- Catalog No. [REF] 10302807 --- MANUFACTURED IN USA AngioDynamics, Inc., 603 Queensbury Avenue, Queensbury, NY USA 12804 || Product Usage: indicated for use in attaining long-term vascular access for Hemodialysis and Apheresis.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Angiodynamics Worldwide Headquarters, 14 Plaza Drive, Latham NY 12110-3421
  • 제조사 모회사 (2017)
  • Source
    USFDA