Events

FLEXSTENT Biliary SelfExpanding Stent System (US Commercial 120 cm Length) 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Cordis 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
    65182
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1509-2013
  • 사례 시작날짜
    2013-04-23
  • 사례 출판 날짜
    2013-06-06
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-06-27
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118257
  • 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, biliary, diagnostic - Product Code FGE
  • 원인
    Holes and/or tears can be introduced in the flexstent¿ inner pouch under some conditions, and to a lesser degree, in the outer pouch.
  • 조치
    Cordis sent an Urgent Medical Device Correction and Potential Removal letter dated April 24, 2013 e-mail to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to immediately identify and set aside all affected products to prevent further use of the affected product, until inspected. ¿ Use only product identified with a blue dot next to the lot number on the carton face label, carton end label, and outer pouch label, or product with upgraded sterile barrier system (not yet available, as of the date of this letter), review, complete, sign and return the enclosed Acknowledgement Form and maintain a copy of this notice with the affected product. For questions related to the issue, please contact our FSS/Cordis representative, or please contact Cordis Direct at (800) 781-0282, Monday through Friday from 9:00 AM to 5:00 PM EDT.

Device

FLEXSTENT Biliary SelfExpanding Stent System (US Commercial 120 cm Length)
  • 모델명 / 제조번호(시리얼번호)
    27 Catalog Numbers   FLX-50030-B2, FLX-60030-B2, FLX-70030-B2, FLX-80030-B2, FLX-50040-B2, FLX-60040-B2, FLX-70040-B2, FLX-80040-B2, FLX-50060-B2, FLX-60060-B2, FLX-70060-B2, FLX-80060-B2, FLX-50080-B2, FLX-60080-B2, FLX-70080-B2, FLX-80080-B2, FLX-50100-B2, FLX-60100-B2, FLX-70100-B2, FLX-80100-B2, FLX-50120-B2, FLX-60120-B2, FLX-70120-B2, FLX-80120-B2, FLX-60150-B2, FLX-70150-B2, FLX-80150-B2
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - USA (nationwide) and the states of: AZ, CA, CT, FL, GA, IA, IL, LA, MD, MI, MS, NC, NJ, NY, OH, PA, RI, SC, TX, WA, WI, WV, and the countries of: Czech Republic, Italy, Netherlands, and New Zealand
  • 제품 설명
    FLEXSTENT Biliary Self-Expanding Stent System. || Product Usage: || The FSS FLEXSTENT Biliary SES product is indicated for use in the palliation of malignant strictures in the biliary tree.
  • Manufacturer
    Cordis Corporation

Manufacturer

Cordis Corporation
  • 제조사 주소
    Cordis Corporation, 14201 Nw 60th Ave, Miami Lakes FL 33014-2802
  • 제조사 모회사 (2017)
    Cardinal Health
  • Source
    USFDA