Events

Retiro De Equipo (Recall) de Device Recall Insulin Infusion Pump

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Smiths Medical MD, Inc..

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    47423
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1591-2008
  • Fecha de inicio del evento
    2008-02-22
  • Fecha de publicación del evento
    2008-09-01
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-01-19
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=69479
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Infusion Pump - Product Code LZG
  • Causa
    Smith medical has received reports of deltec cozmo¿¿ insulin pumps powering down without an alarm. investigation concluded that if the battery cap is not fully tightened, the pump may power down and a brief "chirp" will sound. this may occur if the user has not sufficiently tightened the battery cap or if the battery cap is damaged. if a patient is asleep or does not regularly check their blood gl.
  • Acción
    Consignees and the USA demonstration pump physicians were mailed an "Urgent Medical Device Correction" letter on 2/22/08. The letter stated Details on Affected devices, Description of the problem, Advice on action to be taken by the user, Additional Information and New Warning. These consignees will be required to return the Correction Confirmation Form. The 17 countries with international mailing addresses were sent the Urgent Medical Device Correction letter (Urgent Field Safety Notice) via the Smiths Medical International Regulatory department based in Watford UK. The Smiths Medical Distributors and Affiliates will be required to mail the Safety Notice to their direct users. The USA distributors were mailed the Urgent Medical Device correction letter with a cover letter. These consignees will be required to add the letter to in-house inventory. The USA prescribing physician and the the USA Managed Care Accounts (Insurance Companies) were mailed the Urgent Medical Device Correction letter with a cover letter. These consignees will not be required to respond and no follow-up will be done by Smiths Medical. Contact Mike Herbert at 651-628-7049 if you have any questions or did not receive the recall information from the firm.

Device

Device Recall Insulin Infusion Pump
  • Modelo / Serial
    all serial numbers
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution --- USA including states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, and countries of AU, CA, CL, CN, DE, EG, FR, GB, GR, IL, KW, MX, NL, NZ, ON, PL, SA, SE, TR, UK.
  • Descripción del producto
    Deltec Cozmo¿¿ Insulin Pump, model 21-1800. || This is similar to the currently distributed Deltec Cozmo¿¿ Insulin Pump Model 1700, with the exception of updated software that enhanced certain features and added a food data base to allow users to better manage dietary requirements in conjunction with the use of their insulin pump. || Reorder Numbers: || 21-1801-81 || 21-1803-81 || 21-1804-81 || 21-1805-49/51/81 || 21-1806-49/51/81 || 21-1807-49/51/81 || 21-1815-01/50 || 21-1816-01/50 || 21-1817-01/50
  • Manufacturer
    Smiths Medical MD, Inc.

Manufacturer

Smiths Medical MD, Inc.
  • Dirección del fabricante
    Smiths Medical MD, Inc., 1265 Grey Fox Rd, Saint Paul MN 55112-6929
  • Source
    USFDA