Events

Device Recall CareFusion 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
    72632
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0455-2016
  • 사례 시작날짜
    2015-11-12
  • 사례 출판 날짜
    2015-12-21
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-01-23
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=141712
  • 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
    Analyzer, gas, carbon-dioxide, gaseous-phase - Product Code CCK
  • 원인
    Carefusion is recalling the alaris etco2 module model 8300 because it may have been tested during service using a higher than specified concentration of co2. the effect to the etco2 module tested with a higher concentration of co2 could lead to an incorrect measurement of co2.
  • 조치
    CareFusion sent an Urgent: Medical Device Recall Notification Important letter dated November 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The Alaris EtCO2 Module ( model 8300) is being recalled because it may have been tested during service using a higher than specified concentration of CO2 Customers with questions regarding clinical inquiries, product complaints or clinical troubleshooting are instructed to contact Customer Advocacy at (888) 812-3266 or email at customerfeedback@carefusion.com. Customers with technical questions regarding the Alaris are instructed to contact Technical Support at (888) 812-3229 or by email at DL-US-INF-TechSupport@carefusion.com.

Device

Device Recall CareFusion
  • 모델명 / 제조번호(시리얼번호)
    9905776 9905792 12331254 12350410 12352410 12364342 12364343 12364901 12369088 12401328 12402583 12479923 12481239 12593721 12623833 12623957 12668253 12679872 12697242 12698542 12736367 12805782 12807757 12868325 12870021 12916518 12918611 12919079 12921157 13034011 13034375 13038124 13050300 13050648 13051034 13061112 13072829 13075412 13077962 13088823 13106029 13106030 13106138 13106140 13122164 13122401 13122402 13122936 13136786 13141565 13142603 13143660 13143809 13143889 13167255 13169672 13173261 13177210 13178248 13178389 13178391 13178512 13178968 13178969 13186760 13187737 13188106 13189792 13190670 13216601 13220274 13316434 13316444 13316453 13316473 13316496 13317481 13317552 13317553 13457448 13463929 13464899 13469917 13470004 13470021 13476713 13476912 13477643 13480785 13482441 13482518 13489475 13491251 13521218 13559325 13559686 13569291 13582129 13602388 13621652 13621847 13622337 13624519 13628251 13628876 13628877 13628918 13629153 13658756 13732201 13744088 13781347 13782359 13796475 13809762 13813539 13818275 13853185 13853375 13858182 13858798 13858976 13862567 13867168 13895850 13895989 13896107 13896108 13896110 13896347 13896456 13896669 13896747 13896748 13910604 13922145 13951711 13994625 13995332 14000190 14006401 14035430 14036040 14084571 14084629 14126982 14126990 14151686 14152555 14172846 14190913 14228679 14235981 14253982 14258801 14259542 14280651
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Distribution.
  • 제품 설명
    Alaris EtCO2 Module, Model 8300. A capnograph that continuously monitors end tidal carbon dioxide (EtCO2), fractional inspired carbon dioxide (FiCO2), and respiratory rate (RR).
  • 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