Events

VNUS 7F ClosureFAST Catheter 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 VNUS Medical Technologies 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
    45510
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0543-2008
  • 사례 시작날짜
    2007-08-08
  • 사례 출판 날짜
    2008-01-24
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2008-05-22
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=66271
  • 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 - Product Code GEI
  • 원인
    Instructions for use change: instructions for use have been changed to include a modified placement recommendation.
  • 조치
    The Recalling firm is updating the Instructions For Use, training materials, and procedural guides to incorporate the treatment recommendations. The recalling firm sent an Update to customers who received the product, Important Update Regarding the Use of the VNUS ClosureFAST Catheter, dated August 6, 2007 with supplemental device instructions. Future product distribution will include the updated labeling.

Device

VNUS 7F ClosureFAST Catheter
  • 모델명 / 제조번호(시리얼번호)
    Lot #s: 269157,  269653,  269937,  273326,  277761,  286201,  286565,  287746,  288012,  288336,  288984,  289027,  289757,  291483,  295539,  295786,  296215,  296218,  296974,  298602,  299406,  301347,  301352,  302596,  303252,  304271,  305063,  305550,  306673,  306823,  307368,  308780,  308782,  312677,  312735,  313529,  314828,  314829,  314829,  315084,  315381,  317485,  317827,  317889,  317972,  317979,  318124,  318259,  318556, and  318610,
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide
  • 제품 설명
    VNUS 7F ClosureFAST Catheter, Order # ClF7-7-100 (100 cm working length), Manufactured by VNUS Medical Technologies, Inc., 5799 Fontanoso Way, San Jose, CA 95138
  • Manufacturer
    VNUS Medical Technologies Inc

Manufacturer

VNUS Medical Technologies Inc
  • 제조사 주소
    VNUS Medical Technologies Inc, 5799 Fontanoso Way, San Jose CA 95138-1015
  • 제조사 모회사 (2017)
    Medtronic plc
  • 제조사 의견
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA