Events

BD QSyte Extension Set, Luer access extension 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Becton Dickinson Medical Systems 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
    53749
  • 사례 위험등급
    Class 1
  • 사례 연번
    Z-0752-2010
  • 사례 시작날짜
    2009-10-19
  • 사례 출판 날짜
    2010-02-02
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2010-10-19
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86457
  • 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
    Intravascular administration set. - Product Code FPA
  • 원인
    Manufacturing defect may allow air entry into a central venous catheter, possibly resulting in an air embolism.
  • 조치
    Consignees were notified by B-D Urgent Medical Device Recall letter on 10/28/2009 and asked to return all unused affected lots. For information, call the company at 800-453-4538, option 2, extension 2341. Another letter was sent to all affected customers on 02/08/2010 notifying them of the extension of the recall to include Nexiva products. A response card was included to be returned whether or not product was on hand. B-D issued a press release on Febriuary 8, 2010. It can be found on www.bd.com at http://www.bd.com/contentmanager/b_article.asp?Item_ID=24486&ContentType;_ID=1&BusinessCode;=20001&d;=BD+Worldwide&s;=&dTitle;=&dc;=&dcTitle;=

Device

BD QSyte Extension Set, Luer access extension
  • 모델명 / 제조번호(시리얼번호)
    Lot numbers: 8305511, 8308330, 8354561, 9012072
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide distribution.
  • 제품 설명
    BD Q-Syte Extension Set, 15 cm, P.V. 0.21 ml, REF 385102, Becton Dickinson Infusion Therapy Systems Inc.
  • Manufacturer
    Becton Dickinson Medical Systems

Manufacturer

Becton Dickinson Medical Systems
  • 제조사 주소
    Becton Dickinson Medical Systems, 9450 S State St, Sandy UT 84070-3213
  • Source
    USFDA