Events

SmartSite Extension Set 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 CareFusion 303, 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
    72384
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0221-2016
  • 사례 시작날짜
    2015-10-09
  • 사례 출판 날짜
    2015-11-05
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-03-02
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=140871
  • 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
    Set, administration, intravascular - Product Code FPA
  • 원인
    Carefusion is recalling the smartsite extension set due to disconnection and leakage issues.
  • 조치
    An urgent medical device recall notification was sent to customers on 10/9/15 who purchased the SmartSite Extension Set. The letter informs the customers that CareFusion has identified potential risks with model code 20029E, lot numbers 1503541, 15015769 and 15045950 due to disconnection and leakage issues. The letter also provides the customers with the potential risk involved and the actions to be taken. Customers are instructed to complete and return to CareFusion the recall response card. Customers with recall related questions are instructed to contact CareFusion Support Center at (888) 562-6018. Customers with adverse event reports are instructed to contact Customer Advocacy at (888) 812-3266 or email customerfeedback@carefusion.com. Customers with technical questions regarding technical questions are instructed to contact Technical Support at (888) 812-3229.

Device

SmartSite Extension Set
  • 모델명 / 제조번호(시리얼번호)
    Lot No. 15015769, 15035412, 15045950.
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Distributed US (nationwide) and in Canada.
  • 제품 설명
    SmartSite Extension Set, Model No. 20029E. Used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein.
  • Manufacturer
    CareFusion 303, Inc.

Manufacturer

CareFusion 303, Inc.
  • 제조사 주소
    CareFusion 303, Inc., 10020 Pacific Mesa Blvd, San Diego CA 92121-4386
  • 제조사 모회사 (2017)
    Becton, Dickinson and Company
  • Source
    USFDA