Events

Device Recall DURAMAX Hemodialysis Catheters, Stack Tip 32 cm PreCurve Basic Kit, 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Angiodynamics, Inc. 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
    55701
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1770-2010
  • 사례 시작날짜
    2010-01-08
  • 사례 출판 날짜
    2010-06-04
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-07-25
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91611
  • 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 product has the potential for a cross-lumen leak. one of the two leak testers that are used to perform the leak test on the duramax catheters was found to be faulty. the tester was not able to detect cross-lumen leaks. both testers were used during the manufacturing 100% leak test.
  • 조치
    Customers were sent URGENT MEDICAL DEVICE RECALL LETTERS (dated 1/07/10) via Certified Mail, Return Receipt Requested. Customers were instructed to return all recalled product. A return authorization number was assigned to each customer in the recall notification letter and a UPS account was provided for return freight. A reply form was provided in the recall notification letter. Questions were directed to the company sales representatives or to Customer Service at 800-772-6446.

Device

Device Recall DURAMAX Hemodialysis Catheters, Stack Tip 32 cm PreCurve Basic Kit,
  • 모델명 / 제조번호(시리얼번호)
    Lots 978924, 981851, 981970, C68448, C68449
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide and St. Thomas, VI
  • 제품 설명
    DURAMAX (TM) Hemodialysis Catheters, Stack Tip 32 cm Pre-Curve Basic Kit, Catalog Number/REF 10302814, 510 (k) 080400, Sterile --- Manufactured in USA by AngioDynamics, Inc. 603 Queensbury Avenue, Queensbury, NY 12804
  • Manufacturer
    Angiodynamics, Inc.

Manufacturer

Angiodynamics, Inc.
  • 제조사 주소
    Angiodynamics, Inc., 603 Queensbury Avenue, Queensbury NY 12804
  • 제조사 모회사 (2017)
    AngioDynamics Inc
  • Source
    USFDA