Events

Retiro De Equipo (Recall) de NORMOFLO H1100 Irrigation Fluid Warmers

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
    76190
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1105-2017
  • Fecha de inicio del evento
    2016-10-25
  • Fecha de publicación del evento
    2017-01-26
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-07-25
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152491
  • 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, irrigation solution - Product Code LHC
  • Causa
    Smiths medical became aware that that one (1) normoflo¿ h-1100 irrigation fluid warmers was incorrectly labelled with spanish language labels instead of english labels. specifically five (5) labels were incorrect; the operators manual, outer base box label, pole assembly box label, and two (2) o-ring lube labels.
  • Acción
    Consignee were hand delivered a Smiths Medical Urgent Medical device Filed Safety Notice letter dated October 25, 2016. The letter described the Reason for Field Corrective Action, Risk to Health, and Instructions to Customers. Advised consignees to Provide the device to the Smiths Medical Representative who delivered this notice to you. The Smiths Medical Representative will replace the labeling on the device and packaging, and provide you with the correct English language Operators Manual. Complete the Recall Confirmation Form and return it to Smith Medical via e-mail to FCA.Response@Smiths-medical.com. For questions regarding this notification, please ask the Smiths Medical Representative who delivered the notification or contact Smiths Medical Customer Service Department at +46 859477250.

Device

NORMOFLO H1100 Irrigation Fluid Warmers
  • Modelo / Serial
    S105B0061
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Distribution in the foreign country of Sweden
  • Descripción del producto
    NORMFlow H-110 Irrigation Fluid Warmer, Continental Europe, Model H-1100, Reorder H-1100-INT-230. || Product Usage: || NORMOFLO¿ H-1100 Irrigation Fluid Warmers has been designed for safe, in-line warming of irrigating fluids as they are administered to patients. The Fluid Warmer utilizes a solution reservoir housed in a controller unit (warmer). The recirculation solution is heated to present temperature in the reservoir, pumped though a heat exchanger ( a component of the Sets) and is returned to the reservoir for continuous recirculation. The NORMOFLO Warming products are typically used in clinical situations that may require rapid irrigation with warmed fluids.
  • Manufacturer
    Smiths Medical ASD, Inc.

Manufacturer

Smiths Medical ASD, Inc.
  • Dirección del fabricante
    Smiths Medical ASD, Inc., 1265 Grey Fox Rd, Saint Paul MN 55112-6929
  • Empresa matriz del fabricante (2017)
    Smiths Group Plc
  • Source
    USFDA