Events

BD Vacutainer Plus Plastic Citrate Blood Collection Tubes (Catalog Reference 366560) 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
    79901
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2260-2018
  • 사례 시작날짜
    2018-04-11
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=163870
  • 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 collection - Product Code JKA
  • 원인
    Approximately 3.4% of bd vacutainer plus plastic citrate blood collection tubes (2.7ml) (light blue top tube) will exhibit over fill draw volumes from ~11-14%.
  • 조치
    BD began notifying distributors on April 11, 2018. Customer communications were mailed on April 12-13th, 2018. US customers will be sent a letter via UPS beginning April 12, 2018. Distributors were e-mailed on April 11, 2018 and requested that they provide a list of their consignees to facilitate mailing to end users BD Regions will be contacted via email regarding distribution outside of the US Distributors were instructed to return customer lists to BD. Letters will be mailed with UPS tracking, which provides for a 100% effectiveness check. Customer response form will be tabulated. 100% of non-responders will be contacted by phone.

Device

BD Vacutainer Plus Plastic Citrate Blood Collection Tubes (Catalog Reference 366560)
  • 모델명 / 제조번호(시리얼번호)
    All lots
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US/PR-All 50 states and PR Global-AR, BO, BR, BS, BZ, CA, CO, CR, CW, DO, EC, GT, GY, IN, JM, JP, KR, MX, NI, PA, PE, SG, SR, SV, TT, TW, UY, VI Dates of distribution: June 2, 2017 to the present.
  • 제품 설명
    The BD Vacutainer Plus Plastic Citrate Blood Collection Tube is an evacuated blood collection tube that provides a means of collecting, transporting, and processing blood in a closed tube. The buffered sodium citrate additive provides an anticoagulated specimen that may be used for clinical laboratory coagulation assays.
  • 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