Events

Vacuette Quickshield Complete Plus 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
    62447
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1935-2012
  • 사례 시작날짜
    2012-04-02
  • 사례 출판 날짜
    2012-07-03
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-02-27
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=110651
  • 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 quickshield complete plus may have a defect (split at the base), which can cause the green safety shield attachment of the quickshield holder to be loose and unstable.
  • 조치
    greiner bio-one sent a notification letter dated April 2, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to complete the attached Product Disposition Site Confirmation form and fax to 800-726-0052 or email to patech@gbo.com. This form will confirm the affected product has been discarded/destroyed. The firm will replace the product after the completed form is returned to them. Customers with questions should call 800-515-8112. For questions regarding this recall call 704-261-7823.

Device

Vacuette Quickshield Complete Plus
  • 모델명 / 제조번호(시리얼번호)
    Item #450239, Lot #G110601I and Item #450235, Lot #G110302J.
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution including IL, MS, OH, PA, TN and VA.
  • 제품 설명
    Vacuette Quickshield Complete Plus, 21G x 1 (0.8 x 25 mm), Greiner bio-one. || The Quick shield Complete Plus is intended to be used only with Vacuette Blood collection Tubes as a system in routine venipuncture procedures. They are for single-use only and should only be used by adequately trained healthcare personnel in accordance with instructions for use.
  • 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