Events

Device Recall PRECISE RX 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
    28840
  • 사례 위험등급
    Class 1
  • 사례 연번
    Z-0909-04
  • 사례 시작날짜
    2004-01-13
  • 사례 출판 날짜
    2004-07-20
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2010-08-30
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=32595
  • 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
    Stents, Drains And Dilators For The Biliary Ducts - Product Code FGE
  • 원인
    Air may be introduced into this stent system when used with certain size acessory devices.
  • 조치
    On Jan. 13, 2004 Cordis initiated Sales Representative visits to accounts to provide enhanced Instructions for Use to prevent the air introduction problem which was followed by a Recall Letter to each account providing corrective Instructions for Use on March 29, 2004. Another letter issued on May 4, 2004 recalling the earlier March 29, 2004 letter and modified Instructions for Use, instructing consignees/physicians to only use the device in the biliary tree or liver as indicated in the lableling.

Device

Device Recall PRECISE RX
  • 모델명 / 제조번호(시리얼번호)
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Product was distributed to 415 domestic hospital accounts nationwide and to two related international distributores in Isreal and the Netherlands.
  • 제품 설명
    This medical device is packaged in an inner Tyvek pouch and then in an outer carton. The outer carton is labeled as Cordis PRECISE RX Nitinol Stent Transhepatic Biliary System Cordis a Johnson n Johnson Company ENDOVASCULAR Cat. No. Lot No. Use By. The inner pouch is similarly labled.
  • 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