Events

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

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Smiths Medical MD, Inc..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    50872
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0989-2009
  • Date de mise en oeuvre de l'événement
    2008-11-20
  • Date de publication de l'événement
    2009-04-16
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-06-05
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=77571
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Pump, infusion, insulin - Product Code LZG
  • Cause
    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.
  • Action
    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...
  • Modèle / numéro de série
    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.
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    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.
  • Description du dispositif
    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.
  • Adresse du fabricant
    Smiths Medical MD, Inc., 1265 Grey Fox Rd, Saint Paul MN 55112-6929
  • Source
    USFDA