Events

Retiro De Equipo (Recall) de Nephros Dual Stage Ultra Filter

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 Nephros 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
    66735
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-0490-2014
  • Fecha de inicio del evento
    2013-10-28
  • Fecha de publicación del evento
    2013-12-17
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-07-06
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=123209
  • 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
  • Causa
    Promotional materials for non-medical water filtration products were determined to promote claims which constitute marketing the product as a medical device.
  • Acción
    Nephros Inc., sent an Urgent Medical Device Recall letter dated October 29, 2013 to all affected customers via UPS 2nd Day Air. The letter identified the affected product, problem and actions to be taken. Customer are asked to provide a customer information list, immediately remove and discard all affected product labeling materials and any independent labeling materials they have created for the affected products. Customers are instructed to complete and sign the attached Response Form to acknowledge receipt, understanding and compliance with the instruction. For questions contact the Nephros representative at 201-343-5202 x 100. The letter was also posted at : http://www.nephros.com/download/news/DSU_Recall_Letters.pdf

Device

Nephros Dual Stage Ultra Filter
  • Modelo / Serial
    Item #70-0230; 70-0231; 70-0232; 70-0234; and 70-0235  Document numbers 60-0237 (all) and 60-3003 (all)
  • Distribución
    USA Nationwide Distribution
  • Descripción del producto
    Nephros Dual Stage Ultra Filter (DSU) Brochure || Document 60-3003 || Revisions: 0, 1, 2 || Product Usage: A disposable point of use water ultrafilter that delivers microbiologically pure water for washing and drinking.
  • Manufacturer
    Nephros Inc

Manufacturer

Nephros Inc
  • Dirección del fabricante
    Nephros Inc, 41 Grand Ave, River Edge NJ 07661-1947
  • Empresa matriz del fabricante (2017)
    Nephros, Inc.
  • Source
    USFDA