Transhepatic Biliary Stent System 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
    61713
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1508-2012
  • 사례 시작날짜
    2012-04-09
  • 사례 출판 날짜
    2012-05-10
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2013-12-24
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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 is recalling 32 lots of cordis s.M.A.R.T. nitinol stent transhepatic biliary system and s.M.A.R.T. control nitinol stent transhepatic biliary system. there is a potential for a sterility breach due to holes or tears in the tyvek packaging.
  • 조치
    Cordis Corp sent a " Urgent Medical Device Recall (Removal) letter dated April 9, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. A Response Form was provided with each notification. Customers were asked to complete and return Response Form. The customers were instructed to : " Immediately identify and set aside all product listed above in a manner that ensures the affected product will not be used. " Review, complete, sign and return the enclosed Acknowledgement Form directly to Cordis at the fax number on the form. " Either return any affected product with reference to the RA# on the form, or contact your local sales representative, or contact Customer Service (see Available Assistance section) to facilitate return of the affected product. Replacement product will be provided in a short time frame. Credit will be provided for customer-owned inventory upon request. " Pass on this notice to anyone in your facility that needs to be informed. " If any product listed below has been forwarded to another facility, contact that facility to arrange return. " Maintain awareness of this notice until all product listed above has been returned to Cordis. For questions related to the issue or product replacement, please contact your local sales representative, or contact the special Customer Service number (800) 551-7683, Monday through Friday from 8:30 AM to 8:00 PM EDT.

Device

  • 모델명 / 제조번호(시리얼번호)
    Lot No's. 15535360, 15530747, 15530756, 15530755, 15535363, 15569685, 15530757, 15530754, 15557313, 15530753, 15557311, 15535361.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution-- USA (nationwide) and the country Canada.
  • 제품 설명
    Product is labeled in part: Inner Label "***SMART Control Transhepatic Biliary Stent***REF Cat. No.***Lot No.***Use By***Cordis S.M.A.R.T. CONTROL Nitinol Stent Transhepatic Biliary System***Assembled in Mexico***Cordis Corporation 14201 North West 60th Avenue Miami Lakes, Florida 33014, USA***Cordis S.M.A.R.T. CONTROL BILIARY***Cordis a Johnson & Johnson company***Endovascular***" || Catalog C10080MB Lot No. 15535360. || Catalog C10080SB Lot No. 15530747. || Catalog C12030SB Lot No. 15530756. || Catalog C12040SB Lot No. 15530755. || Catalog C12060SB Lot No's. 15535363, 15569685. || Catalog C12080MB Lot No. 15530757 || Catalog C14040SB Lot No's. 15530754, 15557313. || Catalog C14060SB Lot No's. 15530753, 15557311. || Catalog C14080SB Lot No. 15535361. || Indicated for palliation of malignant neoplasms in the biliary tree.
  • Manufacturer

Manufacturer

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