Events

Retiro De Equipo (Recall) de Device Recall Easy Pump LT 6024

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 I-Flow 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
    50802
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2111-2009
  • Fecha de inicio del evento
    2008-02-11
  • Fecha de publicación del evento
    2009-09-14
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-02-04
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=77342
  • 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, elastomeric - Product Code MEB
  • Causa
    I-flow corporation received two complaints involving easypump lt 60-24 (lot 612996) containing a 100 ml x 2 ml/hr pump in the sterile package instead of a 60 ml x 2 ml/hr pump (illustration was included to show consignee what both the correct and incorrect part looks like). lot 612996 was manufactured on january 6, 2006. as of february 7, 2008, there have been no further complaints received on t.
  • Acción
    I-Flow Corp. issued an "Important Recall Information" letter dated February 7, 2008 informing Consignees to quarantine and return any remaining inventory and notify any end users of the affected lot. For further information, contact I-Flow Corp. at 1-949-206-2653.

Device

Device Recall Easy Pump LT 6024
  • Modelo / Serial
    Lot Number: 612996.
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution to B. Braun, Spain, who then further distributed to Italy, Germany, Netherland, Latvia, Spain, Portugal and Singapore.
  • Descripción del producto
    I-Flow Corporation Easy Pump LT 60-24 (60 ml x 2 ml/hr), REF: 04434366, assembled in Mexico. || The Easypump LT is indicated for continuous and/or intermittent infusion of medication for general infusion use, including antibiotic delivery, chemotherapy and pain management.
  • Manufacturer
    I-Flow Corporation

Manufacturer

I-Flow Corporation
  • Dirección del fabricante
    I-Flow Corporation, 20202 Windrow Dr, Lake Forest CA 92630-8152
  • Source
    USFDA