Events

Device Recall S.M.A.R.T. CONTROL Transhepatic Biliary Stent 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
    61098
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1039-2012
  • 사례 시작날짜
    2012-01-31
  • 사례 출판 날짜
    2012-02-15
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-08-08
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107296
  • 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
    Cordis corporation initiated a recall of s.M.A.R.T. control transhepatic biliary stent due to a potential sterility breach in the pouches.
  • 조치
    All affected consignees were notified by an "Urgent Medical Device Recall (Removal) Letter" dated January 31, 2012 and mailed by overnight delivery on February 1st and 2nd, 2012. Consignees were instructed to identify and quarantine affected product; review, complete, sign, and return an Acknowledgement Form; return the affected product per instructions. Questions should be directed to Customer Service at (800) 551-7683.

Device

Device Recall S.M.A.R.T. CONTROL Transhepatic Biliary Stent
  • 모델명 / 제조번호(시리얼번호)
    Catalog Numbers: C09080MB, C09080SB, C10080MB, C10080SB, C12030MB, C12030SB, C12040MB, C12040SB, C12060MB, C12060SB, C12080MB, C12080SB, C14030MB, C14030SB, C14040MB, C14040SB, C14060MB, C14060SB, C14080MB, C14080SB.
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - USA, and the countries of Japan, Canada, Mexico, South Korea, and Taiwan.
  • 제품 설명
    S.M.A.R.T. CONTROL Transhepatic Biliary Stent. The Self-Expanding Nitinol Biliary Stent is delivered by catheter for the palliation of malignant neoplasms in the biliary tree. || Model numbers are CxxyyyMB, CxxyyySB, CxxyyyML, and CxxyyySL, where xx is the stent diameter in mm and yyy is the stent length in mm; but not including catalogs where yyy is 120 or 150. The Removal only includes Catalog Numbers in the above sequence with S.M.A.R.T¿ CONTROL in the logo/description. All unexpired lot numbers 15112447 through 15525516.
  • 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