Events

Device Recall Prolieve 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Celsion Corporation 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
    35573
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1248-06
  • 사례 시작날짜
    2006-05-04
  • 사례 출판 날짜
    2006-07-19
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-08-04
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=46409
  • 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
    microwave therapy for BPH - Product Code MEQ
  • 원인
    A medical device accessory used by healthcare practitioners in the invasive treatment of (bph) benign prostatic hyperplasia may be defective. the catheter may fail to achieve or maintain recommended pressure.
  • 조치
    Celsion Corporation, the recalling firm, notified consignees by letter 05/04/06 on Boston Scientific Corporation letterhead and advised that the prostatic balloon of the catheter may not achieve and/or maintain the recommended pressure as outlined in the Prolieve User Manual. The notification was sent by courier and included a tracking verification reply form for users to report inventory quantities and to report that all areas of medical facilities holding inventory were checked for recalled product for return via Returned Goods Authorization from contract distributor, Boston Scientific Corporation, Natick, MA.

Device

Device Recall Prolieve
  • 모델명 / 제조번호(시리얼번호)
    581451, 581452, 581464, 581465, 581468, 581471, 581472, 581473, 581474, 581475, 581476, 581477, 581478, 581479, 581480, 600145, 600146, 600147, 600408, 600538, 600540, 600630, 600692, 600771, 600814, 600815, 600874, 600875
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Nationwide. The product was distributed to one distributor in MA and 154 end users in medical centers and urology clinics.
  • 제품 설명
    Prolieve¿ Thermodilatation¿ Kit, consisting of a Prolieve Thermodilatation Catheter, Prolieve Heat Exchanger cartridge and 500 ml bag of sterile water, Catalog # 880-8023, packaged in single packs, Material Number M0068808022, and five packs, Material Number M0068808023, labeled in part *** Distributed by Boston Scientific Corporation, Natck, MA***Manufacturer: Celsion Corporation, Columbia, MD***.
  • Manufacturer
    Celsion Corporation

Manufacturer

Celsion Corporation
  • 제조사 주소
    Celsion Corporation, 10220 Old Columbia Road, Suite L, Columbia MD 21046-2364
  • Source
    USFDA