Events

Device Recall DELTEC COZMO INSULIN INFUSION PUMP WITH COZMONITOR BLOOD GLUCOSE METER, MODELS 211815, 211816, 21 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Smiths Medical MD, 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
    50872
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0989-2009
  • 사례 시작날짜
    2008-11-20
  • 사례 출판 날짜
    2009-04-16
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-06-05
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=77571
  • 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
    Pump, infusion, insulin - Product Code LZG
  • 원인
    Smiths medical has become aware of a display irregularity with the deltec cozmo¿ insulin pump, model 1800 and model 21-1700 containing model 1800 software. there have been adverse events reported that the amount of extended bolus delivered was not accurately displayed by the pump. the amount of extended bolus displayed on the pump home screen 2 and in the bolus summary report is less than what w.
  • 조치
    Consignees were sent a Smiths Medical "Urgent Device Recall" letter dated November 20, 2008. The letter was addressed to Distributors, Clinicians, Patients and other Customers. The letter included a Description of the Problem, Advice on Action to be Taken by the User and requested the return of the Confirmation Form. In particular, users were given the option to check the "Replacement Pump" option on the Confirmation Form initiating the process for pump replacement with a recertified pump followed by a return of the defective product. The Confirmation Form can be faxed to 1-800-628-6322 in the U.S. or 1-651-628-7485 outside the U.S., completed at www.cozmore.com/notice or calling 1-800-501-5748 in the U.S.

Device

Device Recall DELTEC COZMO INSULIN INFUSION PUMP WITH COZMONITOR BLOOD GLUCOSE METER, MODELS 211...
  • 모델명 / 제조번호(시리얼번호)
    Product Numbers: 21-1705-79 21-1705-89 21-1706-79 21-1706-89 21-1707-79 21-1707-89 21-1715-19 21-1716-19 and 21-1717-19.
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution --- Including states of AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MI, MA, MD, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, WY and DC and countries of AUSTRALIA, NEW ZEALAND, UNITED KINGDOM, IRELAND, CANADA, CHINA, GREECE, POLAND, SLOVENIA, SWEDEN, ISRAEL and BRAZIL.
  • 제품 설명
    Deltec Cozmo¿ Insulin Pump, Model 1700 containing 1800 software. || Deltec Cozmo¿ Insulin Pumps are ambulatory electromechanical pumps used for delivering insulin to patients with diabetes. The pump is used mainly by homecare patients, but can also be used in a healthcare facility.
  • Manufacturer
    Smiths Medical MD, Inc.

Manufacturer

Smiths Medical MD, Inc.
  • 제조사 주소
    Smiths Medical MD, Inc., 1265 Grey Fox Rd, Saint Paul MN 55112-6929
  • Source
    USFDA