Events

Retiro De Equipo (Recall) de Device Recall FloGard 6201 Volumetric Infusion Pumps

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 Baxter Healthcare Corp..

¿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
    31965
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1552-05
  • Fecha de inicio del evento
    2005-05-03
  • Fecha de publicación del evento
    2005-09-21
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-03-04
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=38825
  • 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 - Product Code FRN
  • Causa
    The mounting screws of the pole clamp may come loose, allowing the pole clamp assembly to detach from the rear pump housing, if they are not maintained on at least an annual basis.
  • Acción
    Safety Alert letters dated 5/3/05 were sent to all Flo-Gard 6201 and 6301 Volumetric Infusion Pump customers. The letters informed the users of the potential for the pole clamp mounting screws to come loose, and recommended that they inspect the Flo-Gard pole clamp during their routine maintenance or as part of the recommended annual preventative cycle. If the pole clamp appears to be loose, the users were provided with the following steps to be followed to ensure that the pole clamp is properly secured: a) The recessed area in the housing for the clamp body must be clean. b) The three mounting screw holes in the housing must not show signs of cracking. c) The ground wire must be attached to the center screw. d) The screws must be M4x10 with captive washer. e) Loctite 425 threadlocker must be applied to each of the three screws. f) Torque the screws to 7.8 in-lb. Enclosed was a copy of the Service Bulletin issued in April 2002 with additional information about servicing the Flo-Gard pole clamps.

Device

Device Recall FloGard 6201 Volumetric Infusion Pumps
  • Modelo / Serial
    all serial numbers
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide including USA, Puerto Rico, Argentina, Australia, Bahrain, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Costa Rica, Denmark, Ecuador, Egypt, El Salvador, Guatemala, Hong Kong, Honduras, India, Indonesia, Ireland, Italy, Korea, Lebanon, Malaysia, Mexico, Netherlands, New Zealand, Nicaragua, Norway, Oman, Panama, Peru, Philippines, Poland, Russia, Singapore, Slovakia, Slovenia, South Africa, Sweden, Taiwan, Thailand, Turkey, United Kingdom and Venezuela.
  • Descripción del producto
    Baxter Flo-Gard 6201 Volumetric Infusion Pump, catalog #2M8063, 2M8063R (refurbished); Baxter Healthcare Corporation, Deerfield, IL 60015
  • Manufacturer
    Baxter Healthcare Corp.

Manufacturer

Baxter Healthcare Corp.
  • Dirección del fabricante
    Baxter Healthcare Corp., Rt. 120 & Wilson Rd, Round Lake IL 60073
  • Source
    USFDA