Events

Retiro De Equipo (Recall) de Device Recall Smiths Medical HOTLINE 3 Blood and Fluid Warmer

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 Smiths Medical ASD, 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
    62389
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1979-2012
  • Fecha de inicio del evento
    2012-06-27
  • Fecha de publicación del evento
    2012-07-09
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-02-20
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=110397
  • 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
    Warmer, thermal, infusion fluid - Product Code LGZ
  • Causa
    Hotline 3 blood and fluid warmer( reorder no. hl-390 ) disposable is not correctly installed , the microswitch may become damaged and unusable.
  • Acción
    Smiths Medical sent an Urgent Medical Device Correction -Field Safety Notice letter dated June 21, 2012 via U.S. Mail to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter included an Urgent Medical Device Field Safety Notice Acknowledgement Form ("Confirmation Form") that customers were instructed to complete and return to Smiths Medical for carrying out the correction and affectivity tracking purposes. The letter stated that a Smiths Medical Representative will visit the affected sites to correct the units with a shelf upgrade kit, which includes instructions and all the parts necessary to make the correction to their affected devices. Customers were provided with a form to record the serial numbers of the devices corrected so that this can be returned to Smiths Medical. For questions regarding this information call Smiths Medical Quality Department at 1-781-763-9335. .

Device

Device Recall Smiths Medical HOTLINE 3 Blood and Fluid Warmer
  • Modelo / Serial
    All serial numbers
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Nationwide Distribution
  • Descripción del producto
    Smiths Medical HOTLINE 3 Blood and Fluid Warmer, || Reorder Numbers: HL-390 || Product Usage: || The Micro-switch is used on the HOTLINE¿ 3 Blood and Fluid Warmer. This product, for use in conjunction with HOTLINE¿ 3 L-370 Fluid Warming Set are intended for the delivery of warmed blood and intravenous fluids at normothermic temperatures. These products are intended for use by appropriately trained healthcare professionals in clinical environments
  • Manufacturer
    Smiths Medical ASD, Inc.

Manufacturer

Smiths Medical ASD, Inc.
  • Dirección del fabricante
    Smiths Medical ASD, Inc., 160 Weymouth St, Rockland MA 02370-1136
  • Source
    USFDA