STAT 2 I.V. Controller 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 ConMed Corporation 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
    60702
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0629-2012
  • 사례 시작날짜
    2011-04-15
  • 사례 출판 날짜
    2012-01-11
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2013-01-15
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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
    Controller, infusion, intraascular, electronic - Product Code LDR
  • 원인
    Conmed received complaints of some units exhibiting inaccurate or inconsistent flow rates. it was determined that certain units were assembled with an incorrect component which could result in the devices exhibiting a different flow rate and might reduce the ability of the user to regulate the device at low flow rates.
  • 조치
    ConMed Corporation sent Urgent Medical Device Recall Letters and Response Forms dated April 14, 2011, via UPS Priority Mail pouches to all domestic consignees. The letter identified the product, the problem, and the action to be taken by the consignee. The international consignees were sent Urgent Medical Device Recall Letters and Response Forms dated April 22, 2011, via FedEx International Priority. Users were instructed to immediately stop use of the device and return it to ConMed Corporation. --- RECALL EXPANSION: Consignees were also instructed to contact all of those organization within their facility and any other facilities that they may have supplied or given these affected products to. ConMed Corp. sent out Amended Urgent Medical Device Recall Letters and Response Forms dated May 10, 2011, to the 4 consignees via UPS PriorIty Mail for the expansion of the recall for Catalog No. S2-12N, Lot 1006234. For any questions call 315-624-3237 or email ivcontroller@conmed.com.

Device

  • 모델명 / 제조번호(시리얼번호)
    Beginning Lot Code 1007195, Ending Lot Code 1010085
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) and the countries of Canada, Panama and India
  • 제품 설명
    STAT 2 I.V. Controller, Catalog/REF No. S2, ASSEMBLED IN MEXICO, CONMED CORPORATION, 525 FRENCH ROAD, UTICA, NY 13502 --- This is a disposable device with a sterile, nonpyrogenic fluid path. || For controlling the infusion of Intravenous fluids into the human body.
  • Manufacturer

Manufacturer

  • 제조사 주소
    ConMed Corporation, 525 French Road, Utica NY 13502
  • 제조사 모회사 (2017)
  • Source
    USFDA