Events

Retiro De Equipo (Recall) de Device Recall Spectra Optia Apheresis System

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 Caridian BCT, Incorporated.

¿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
    58909
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2674-2011
  • Fecha de inicio del evento
    2010-12-09
  • Fecha de publicación del evento
    2011-06-28
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-09-12
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100504
  • 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
    Separator, automated, blood cell and plasma, therapeutic - Product Code LKN
  • Causa
    An additional air detection system is being added to all existing systems to detect air in the system's return line.
  • Acción
    CaridianBCT sent a "MEDICAL DEVICE RECALL" letter dated December 2010 to all customers. The letter describes the product, problem, and actions to be taken by the customers. Customers were advised to continue using their systems as long as they followed the instructions in the Operator's Manual. An Acknowledgement of Receipt form was included with the letter to be completed and faxed to 1-303-876-9277 or e-mailed to Regulatory.Affairs@caridianbct.com. A CaridianBCT representative will schedule a visit to facilities to upgrade their systems within the next 6 months. Further information is available by contacting the CaridianBCT Support Center at 877-339-4228 or 303-231-4357.

Device

Device Recall Spectra Optia Apheresis System
  • Modelo / Serial
    Serial Numbers: 1P00100 thru 1P00719
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution--USA (nationwide) and countries of Australia, Belgium, Canada, China, Hong Kong, Japan, Malaysia, Mexico, Pakistan, Saudi Arabia, Singapore, South Korea, Taiwan, Thailand, and Vietnam.
  • Descripción del producto
    Spectra Optia Apheresis System, REF: 61000, CaridianBCT, Lakewood, CO 80215. || The Spectra Optia Apheresis System, a blood component separator, is intended for use in therapeutic apheresis applications. The system may be used to perform Therapeutic Plasma Exchange, Mononuclear Cell Collection, and Red Blood Cell Exchange.
  • Manufacturer
    Caridian BCT, Incorporated

Manufacturer

Caridian BCT, Incorporated
  • Dirección del fabricante
    Caridian BCT, Incorporated, 10811 W Collins Ave, Lakewood CO 80215-4440
  • Empresa matriz del fabricante (2017)
    Terumo Corp.
  • Source
    USFDA