Events

Retiro De Equipo (Recall) de Device Recall Medex 2000

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 Medex 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
    26633
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1060-03
  • Fecha de inicio del evento
    2003-06-09
  • Fecha de publicación del evento
    2003-07-29
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2006-03-13
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=28036
  • 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
    unknown device name - Product Code CAJ
  • Causa
    Inadequate warning label as pertains to use of the pump in conjunction with extracorporeal membrane oxygenation (ecmo) procedures.
  • Acción
    Consignees were notified via letter dated June, 2003. The firm provided each consignee with a warning label to be affixed to all pump and to the front cover of the Instruction Manual.

Device

Device Recall Medex 2000
  • Modelo / Serial
    Series #2001, 2201E, 2001G, 2001H, 2001VX, 2001HZE, 2001NFHU, 2001T, 2010, 2010E, 2010H, 2010HVX, 2010HZE, 2010i, 2010iK, 2010iVX, 2010iZE
  • Distribución
    Units were distributed to medical facilities nationwide and worldwide.
  • Descripción del producto
    Medex 2000 Series Syringe Infusion Pumps. The 2001 series is a general use pump, 2001E is for German use, 2001G is for use in the UK, 2001T is for use in Taiwan, 2010iK is for use in Korea (the pumps with different languages have different syringes than those used in the U.S.), 001H has a different power cord connector, ''VX in the suffix means it is an evaluation pump, ''NFHU is not for human use; used in test labs for testing purposes, 2010 has an anesthesia mode built into the software, ''ZE are returned because of outdated software. They are refurbished or upgraded and re-distributed, 2010i, has an anesthesia mode and library mode for programming.
  • Manufacturer
    Medex Inc

Manufacturer

Medex Inc
  • Dirección del fabricante
    Medex Inc, 4350 River Green Parkway, Suite 200, Duluth GA 30096
  • Source
    USFDA