Events

Retiro De Equipo (Recall) de Device Recall 2008T Hemodialysis Machine

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 Fresenius Medical Care Holdings, 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
    70574
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1550-2015
  • Fecha de inicio del evento
    2015-02-20
  • Fecha de publicación del evento
    2015-04-29
  • Estado del evento
    Completed
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=135407
  • 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
    Dialyzer, high permeability with or without sealed dialysate system - Product Code KDI
  • Causa
    The acetate value for granuflo on the select concentrate screen should be 8meq/l but it is displayed as 4meq/l. the correct value is shown on the dialysate screen.
  • Acción
    The firm, Fresenius Medical Care, sent an "URGENT - MEDICAL DEVICE CORRECTION" letter dated February 19, 2015 to its Consignees via certified mail on February 26, 2015. The letter describes the product, problem and actions to be taken. The consignees were instructed to sign and return the attached "Reply Form" via fax to: 781-699-9769 Attn: Quality Department or Scan and E-mail to: NOTIFYRA@fmc-na.com to confirm that they received and understand the customer notification. The firm will be providing a software update and stated that in the near future, your local clinic will be contacting you about installing the software update. If you have any questions pertaining to this Customer Notification, please contact your local clinic, 800-227-2572 or the Corrections and Removals Manager at 800-662-1237.

Device

Device Recall 2008T Hemodialysis Machine
  • Modelo / Serial
    Serial Numbers: 0T0S100031- 101358, 1T0S101359- 127938, 2T0S109489- 118130, 3T0S118131- 126163, 4T0S126164- 135408, 9T0S100002, 9T0S100004, 9T0S100007- 100010, 9T0S100012, 9T0S100014- 100016
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution: US (Nationwide) and countries of: Canada and Mexico.
  • Descripción del producto
    2008 Series Hemodialysis Machines: 2008T with the following product code and description: 190395 2008K at Home System - 1st Gen. -¿ Canada; || 190828 2008K at Home System - 2nd Gen - U.S.; 190904 2008K at Home System w/ Bibag; 190828 2008KatHOME HEMODIALYSIS SYSTEM; || 190395 2008KatHOME MACHINE, SHORT CAB, OLC/DP, HP || The Fresenius 2008K is indicated for acute and chronic dialysis therapy.
  • Manufacturer
    Fresenius Medical Care Holdings, Inc.

Manufacturer

Fresenius Medical Care Holdings, Inc.
  • Dirección del fabricante
    Fresenius Medical Care Holdings, Inc., 920 Winter St, Waltham MA 02451-1521
  • Empresa matriz del fabricante (2017)
    Fresenius SE & Co KGaA
  • Source
    USFDA