Events

Retiro De Equipo (Recall) de ColorSafe IV Administration sets and components

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 Codan Us Corporation.

¿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
    68591
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2040-2014
  • Fecha de inicio del evento
    2011-08-17
  • Fecha de publicación del evento
    2014-07-10
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-07-10
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128284
  • 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
    Set, administration, intravascular - Product Code FPA
  • Causa
    Codan us corporation is recalling the colorsafe iv (intravenous) product lines because they were manufactured and marketed prior to fda approval.
  • Acción
    CODAN sent a recall letter dated August 17, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to return any of the affected product. If they sold the product they should provide Codan the name and address of the customer. so that they may be contacted to retrieve the shipped products. Customers were instructed to contact CODAN Customers Service for a Returned Goods Authorization. Customers with questions were instructed to call 714-430-1303. Customers were instructed to not send used devices.For questions regarding this recall call 714-545-2111.

Device

ColorSafe IV Administration sets and components
  • Modelo / Serial
    Lot No.  71701, 90391, 71716, 90386, 72155, 71704, 90392, 72473, 72398, 72561, 72934, 90387, 72156, 71707, 90393, 72564, 90388, 72157, 71710, 90394, 71719, 90389, 72159, 71713, 90395, 71720, 90390, 72158.
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US including TX, CT, NY and Internationally to Belgium.
  • Descripción del producto
    ColorSafe IV lines || Catalog No.(Model No.) || CS3000-R (76.7806), || CS400-R (76.7800), || CS408N-R (76.8000), || CS3000-B (76.7807), || B314 (25.7406), || CS400-B (76.7801), || CS408N-B (76.8001), || CS3000-O (76.7808), || CS400-O (76.7802), || CS408N-O (76.8002), || CS3000-G (76.7809), || CS400-G (76.7803), || CS408N-G (76.8004), || CS3000-P (76.7810), || CS400-P (76.7804), || CS408N-P (76.8003). || Intravenous administration sets
  • Manufacturer
    Codan Us Corporation

Manufacturer

Codan Us Corporation
  • Dirección del fabricante
    Codan Us Corporation, 3511 W Sunflower Ave, Santa Ana CA 92704-6944
  • Empresa matriz del fabricante (2017)
    Codan Medical Holding Aps
  • Source
    USFDA