Events

B. Braun Outlook Safety Infusion System Burette Set 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 B. Braun Medical, 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
    65993
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2166-2013
  • 사례 시작날짜
    2013-08-05
  • 사례 출판 날짜
    2013-09-06
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-09-03
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121164
  • 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
    Pump, infusion - Product Code FRN
  • 원인
    Reports were received of an incorrectly assembled outlook safety infusion system burette set (product code 375038), and the investigation determined that one of the ultrasite injection sites and corresponding low pressure backcheck valve was assembled upside down.
  • 조치
    On August 4, 2013, a letter was sent to direct accounts asking them to check their inventory for the affected product. These customers were also instructed to notify their customers if the product was further distributed and to return all affected product and/or the product removal acknowledgement form.

Device

B. Braun Outlook Safety Infusion System Burette Set
  • 모델명 / 제조번호(시리얼번호)
    Catelog Number 375038, Lot Number 0061317318, Expiration Date: 04/30/2016
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Distributed in the states of FL, NY, NJ, and TX.
  • 제품 설명
    Outlook Safety Infusion System Burette Set. || For intravenous fluid administration.
  • Manufacturer
    B. Braun Medical, Inc.

Manufacturer

B. Braun Medical, Inc.