Events

Device Recall SmartSite 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
    75013
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1883-2017
  • 사례 시작날짜
    2016-11-17
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149125
  • 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 add-on bag device due to reports of separation and/or leakages between the spike port and the drip chamber spike. a separation or leak can cause a delay of infusion, an interruption of infusion, exposure to medication or hazardous infusates, or underinfusion.
  • 조치
    CareFusion sent an Urgent Medical Device Recall Notification letter dated November 2016, to inform their customers that CareFusion is recalling the SmartSite Add-On Bag Access Device Model 10013365 because of reports of leakages between the spike port and the drip chamber spike. The letter informs the customers of the lot numbers, potential risk and immediate actions to be taken. Customers with questions are instructed to contact CareFusion Support Center at (888) 562-6018 for recall related questions. Customers with adverse event report questions are instructed to contact Customer Advocacy at (888) 812-3266 or by email at customerfeedback@carefusion.com. Customers are instructed to complete and return the enclosed mandatory customer response card.

Device

Device Recall SmartSite
  • 모델명 / 제조번호(시리얼번호)
    15055146 15055702 15056299 15056618 15065645 15075740 15076166 15076167 15076664 15076729 15077085 15085031 15085156 15086107 15095014 15095411 15106928 15116928 15125952 15126069 15127413 16015324 16015325 16015607 16025824 16025948 16027008 16035527 16036131
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Distribution
  • 제품 설명
    SmartSite Add-On Bag Access Device, Model No. 10013365
  • 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