Events

Prolieve¿ Thermodilatation¿ Kit, consisting of a Prolieve Thermodilatation Catheter, Prolieve Heat Exchanger cartridge and 500 ml bag of sterile water, Catalog # 880-8023, Material Number M0068808023, labeled in part *** Distributed by Boston Scientific Corporation, Natck, MA***Manufacturer: Celsion Corporation, Columbia, MD***. 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Celsion Corporation, 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
    34988
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-0843-06
  • 사례 시작날짜
    2006-03-22
  • 사례 출판 날짜
    2006-05-06
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2007-02-07
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=45077
  • 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
    System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy - Product Code MEQ
  • 원인
    Surgical treatment kits containing medical device components were mislabeled with extended expiration dates.
  • 조치
    The recalling firm notified the contract distributor on 2/17/06 to cease shipments. The distributor subsequently notified accounts on 3/22/06 with lot and shipment specific recall letters. The letters advised that consignees discontinue use of the affected lots for return to the distributor. Consignees were requested to return the reply verification form enclosed.

Device

Prolieve¿ Thermodilatation¿ Kit, consisting of a Prolieve Thermodilatation Catheter, Prolieve Hea...
  • 모델명 / 제조번호(시리얼번호)
    Lot 600783 Exp Feb-08 Lot 600815 Exp Jan-08 Lot 600874 Exp Feb-08 Lot 600875 Exp Jan-08 Lot 600814 Exp Jan-08 Lot 600771 Exp Jan-08 Lot 600692 Exp Dec-07 Lot 600540 Exp Nov-07 Lot 600630 Exp Dec-07 Lot 600538 Exp Dec-07 Lot 600408 Exp Dec-07 Lot 600145 Exp Sep-07 Lot 600146 Exp Sep-07 Lot 600147 Exp Sep-07
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Products were distributed to one distributor in MA and eight medical device users in MA, IL, NJ, FL, NY, CO, OH, and MI.
  • 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, Material Number M0068808023, labeled in part *** Distributed by Boston Scientific Corporation, Natck, MA***Manufacturer: Celsion Corporation, Columbia, MD***.
  • Manufacturer
    Celsion Corporation, Inc.

Manufacturer

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