Events

Device Recall SmartSite Needleless Connector 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
    67346
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0925-2014
  • 사례 시작날짜
    2014-01-22
  • 사례 출판 날짜
    2014-02-03
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-08-06
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125296
  • 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 needlefree connector, model number 2000e, because of connection issues. the affected smartsite connector lots may unintentionally disconnect from a female luer, may be difficult to disconnect from a female luer, or may fail to disconnect from a female luer once attached. leakage may also be observed if the connector disconnects from the female luer during in.
  • 조치
    The firm, CareFusion, sent an "URGENT: Medical Device Recall Notification" letter dated January 22, 2014 to customers. The letter described the product, problem and actions to be taken. Customers were instructed to discontinue use of the listed lot numbers, contact CareFusion for a replacement of the affected lots, and if you have inventory of the listed products immediately complete and return to CareFusion the enclosed, pre-addressed and postage paid, Recall Response Card. All recalled product should be returned directly to the distributor from whom it was purchased. If you have any question, contact your distributor directly or call the CareFusion Support Center at numbers below. For recall related questions, customers are instructed to contact CareFusion Support center at (888) 562-6018. For adverse event reports, customers are instructed to contact Customer advocacy at (888) 812-3266 or email customerfeedback@carefusion.com. For technical questions regarding the Alaris System, customers are instructed to contact technical support at (888) 812-3229.

Device

Device Recall SmartSite Needleless Connector
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers:  13045933 13046117 13086415 13086446 13095237 13095302 13095324 13095579 13095674 13095675 13095777 13095778 13095808 13095944 13096011 13096012 13096013 13096158 13096723 13096770 13105584 13106017 13106018 13106096 13106260 13106355 13106451 13106497 13106498 13106753 13106754 13106847 13106848 13106849 13115209 13115210 13115317 13115733 13115734 13115871 13115872 13125361 13125362
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution: US (nationwide) including Puerto Rico; and internationally to: Australia, Canada and New Zealand.
  • 제품 설명
    SmartSite Needleless Connector, Model No. 2000E || The SmartSite Needleless Connectors are sterile, individually packaged connectors. The connectors are used to administer fluid and medications. The needle free connector allows the user to add medication into the primary line without the use of a needle.
  • 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