Events

PC Holdex 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
    49367
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2198-2008
  • 사례 시작날짜
    2008-08-05
  • 사례 출판 날짜
    2008-09-30
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-07-25
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73213
  • 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 - Product Code FMI
  • 원인
    At removal of the tube from the holder the needle may dislodge and become stuck in the tube stopper with the blunt end of the needle facing out.
  • 조치
    Consignees were notified by letter on 08/06/2008. Letters to Distributors instructed them to stop distribution of the affected product immediately and to hold any product of the lots they may have pending returned to Greiner bio-one. The were instructed to provide Greiner bio-one with a list of their customers who may have received the affected lot so that they can contact them. A Product Disposition form was included to be completed and returned to Greiner bio-one. Contact Greiner Bio-One North America, Inc. at 1-888-286-3883 for assistance.

Device

PC Holdex
  • 모델명 / 제조번호(시리얼번호)
    Lot#: A030804
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    AL, FL, IN, KS, KY, MO, MN, NC, OH, PA, TN, TX, UT, VA, WI and WV.
  • 제품 설명
    Plastic Cannula Holdex¿ Tube Holder, Item number: 450216. It is intended for use in routine specimen withdrawal from specimen collection bags or bottles through needleless cannula ports.
  • 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 28110-7681
  • 제조사 모회사 (2017)
    Greiner Holding Ag
  • Source
    USFDA