Events

Device Recall Model 4000 CMS Ambulatory Infusion Pump 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Curlin Medical Llc 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
    48639
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1898-2008
  • 사례 시작날짜
    2008-05-30
  • 사례 출판 날짜
    2008-09-22
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2009-06-11
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=71775
  • 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
    Infusion Pump - Product Code FRN
  • 원인
    Over-delivery/free-flow involving curlin ambulatory peristaltic multi-therapy infusion pumps where the pumping chamber door (platen) had become deformed in a manner that permitted gravity flow.
  • 조치
    On May 30, 2008, Curlin Medical began distribution of a "Voluntary Field Correction Advisory Notice" to all customers in the United States via USPS Registered Mail. The Notice informed customers of the problem and gave the customers (1) Guidelines on testing pump volumetric accuracy, (2) Updated user manuals to elevate the "caution" statement related to dropped pumps to a "warning" statement, and (3) A warning label to be located on the pump: "Warning: Impact may cause damage. If dropped, pump must be checked for accuracy prior to use". A toll free number (888-287-5999) was given for customers experiencing issues that require immediate assistance.

Device

Device Recall Model 4000 CMS Ambulatory Infusion Pump
  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers for all affected units: 100074 to 210458
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution --- including USA and countries of Australia, Croatia, Germany, Italy, New Zealand, and South Africa.
  • 제품 설명
    Model 4000 CMS Ambulatory Infusion Pump, Model Number: 350-1101
  • Manufacturer
    Curlin Medical Llc

Manufacturer

Curlin Medical Llc
  • 제조사 주소
    Curlin Medical Llc, 15751 Graham St, Huntingtn Bch CA 92649-1630
  • 제조사 모회사 (2017)
    Moog Inc
  • Source
    USFDA