Events

Device Recall Becton Dickinson Buffered Sodium Citrate (9NC) Plus Blood Collection Tubes 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Becton Dickinson & Company 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
    64010
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0756-2013
  • 사례 시작날짜
    2012-11-12
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-09-06
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115207
  • 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
    Tubes, vials, systems, serum separators, blood - Product Code JKA
  • 원인
    Bd is conducting a recall of the bd vacutainer 2.7ml plus citrate blood collection tube due to extended partial thromboplastin time (aptt) test results reported in two customer complaints.
  • 조치
    BD sent "ATTENTION: PRODUCT RECALL" letters dated November 12, 2012 via UPS to distributors and customers instructing them to examine their inventory immediately and discontinue the shipment of the affected product. All customers were instructed to return all products from the lot affected, by following the instructions on the enclosed packing slip,and BD will send them replacement products at no charge. Contact the firm at 10201-847-4267 for assistance.

Device

Device Recall Becton Dickinson Buffered Sodium Citrate (9NC) Plus Blood Collection Tubes
  • 모델명 / 제조번호(시리얼번호)
    Lot No. 2180434; Expiration Date: April 2013
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution-USA (nationwide) and the countries of Canada, India, Japan, Nepal, Malaysia, Singapore, Brazil, Costa Rica, and Virgin Islands.
  • 제품 설명
    BD Vacutainer Buffered Sodium Citrate (9NC) Plus Blood Collection Tubes; Sterile; IVD; REF 363083; 13 X 75 mm, 2.7 mL
  • Manufacturer
    Becton Dickinson & Company

Manufacturer

Becton Dickinson & Company
  • 제조사 주소
    Becton Dickinson & Company, 1 Becton Dr, Franklin Lakes NJ 07417-1815
  • 제조사 모회사 (2017)
    Becton, Dickinson and Company
  • Source
    USFDA