Events

Retiro De Equipo (Recall) de Deltec Cozmo 3 mL Insulin Cartridge

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
    30401
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0566-05
  • Fecha de inicio del evento
    2004-10-15
  • Fecha de publicación del evento
    2005-02-26
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2006-06-25
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=35809
  • 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
    Pump, Infusion, Insulin - Product Code LZG
  • Causa
    Smiths medical md, inc. (smmd) has received several complaints relating to two lots of cozmo cartridges describing leakage of insulin into the cartridge chamber. firm expanded recall 03/17/05 to include one more lot, based on in-house testing and review of customer complaints.
  • Acción
    Consignees were mailed Customer Recall Notification Letter on 10/15/04. Customers are to inspect their inventory for the affected lot numbers and contact Smiths Medical Customer Services Department and return any unused Insulin Cartridges to Smiths Medical, who will replace the returned Insulin Cartridges. EXPANDED RECALL Customers were notified with an Urgent: Product Safety & Recall Notification beginning 03/17/05 with similar instructions as in the previous Notification. Customers are to inspect their inventory for the affected lot number, contact Smiths Medical Diabetes System Customer Service Department to make arrangements to have the unused Insulin Cartridges from the affected lot number returned to Smiths Medical, who will provide replacement cartridges.

Device

Deltec Cozmo 3 mL Insulin Cartridge
  • Modelo / Serial
    Cartridge Lot Number 005X64 reorder # 21-1750-24 and Cartridge Lot Number 007X64 Reorder # 21-1750-24. EXPANDED RECALL 03/17/05 to include lot #009X64
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    nationwide. Product only distributed within the US.
  • Descripción del producto
    Deltec Cozmo 3 ml Insulin Cartridge with 0.7mm(22G) x 12.5mm (1/2 in.) needle and cap. Reorder No. 21-1750-24. Immediate container states STERILE EO, Rx Only , Deltec, Inc., St. Paul, MN 55112. Additional labeling states Cartridge is Sterile and nonpyrogenic unless package is opened or damaged. do not use if package is opened or damaged, or if product appears damaged. Made in Mexico for: Deltec 1265 Grey Fox Road, St. Paul, MN 55112 USA, Smiths, smiths Medical - a part of Smiths Group plc.
  • 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