Events

Device Recall VACUETTE Safety Blood Collection Set Luer Adapter 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Greiner Bio-One North America, 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
    64321
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0835-2013
  • 사례 시작날짜
    2013-02-01
  • 사례 출판 날짜
    2013-02-15
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-10-29
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115829
  • 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
    Needle, hypodermic, single lumen - Product Code FMI
  • 원인
    The vacuette safety blood collection set + luer adapter may display leaking (small droplets) during use due to a crack on the luer connector piece.
  • 조치
    Greiner Bio-One sent a notification letter dated January 31, 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to stop distributing the affected product, complete the attached Product Disposition form and fax to GBO at 800-726-0052 or email to patech@gbo.com. GBO will contact customers for the return of the affected product after receiving the attached Product Disposition form. Customers were requested to provide the names of customers who may have received the product. For questions call 800-515-8112.

Device

Device Recall VACUETTE Safety Blood Collection Set Luer Adapter
  • 모델명 / 제조번호(시리얼번호)
    Lot No. 12H27
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Nationwide Distribution in the states of FL, IL, KY, NY, NC, PA, OH, TX, VA
  • 제품 설명
    VACUETTE Safety Blood Collection Set + Luer Adapter, 23x12" Safety Blood Collect LA Product, Item number 450096. Usage: The Safety Blood Collection Set is used in routine venipuncture procedures.
  • Manufacturer
    Greiner Bio-One North America, Inc.

Manufacturer

Greiner Bio-One North America, Inc.
  • 제조사 주소
    Greiner Bio-One North America, Inc., 4238 Capital Dr, Monroe NC 28110
  • 제조사 모회사 (2017)
    Greiner Holding Ag
  • Source
    USFDA