Events

Retiro De Equipo (Recall) de Device Recall Fresenius ASSEMBLY, POWER SUPPLY

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
    70027
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1015-2015
  • Fecha de inicio del evento
    2014-12-16
  • Fecha de publicación del evento
    2015-01-27
  • 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=132154
  • 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
    Unqualified power assemblies shipped to customers.
  • Acción
    Consignees were notified of the recall via letter sent on 12/18/2014 via certified mail. The letter informs consignees of the recall and requests that they take the following steps: Please check your stock for any 50 Hz Power Supplies (P/N 190092) with the name Electro Assemblies, LLC which is visible on the Transformer contained inside the Power Supply and discontinue use. Place the product in a secure, segregated area. Please contact your Fresenius Technical Services at 1-800-227-2572 option 4 then option 1, and reference the Field Action Number above. They will issue you a Return Good Authorization so you can return this product. that a reply form is completed and returned via fax or scanned email copy. In addition, consignees are asked to complete a reply form and return via fax/mail.

Device

Device Recall Fresenius ASSEMBLY, POWER SUPPLY
  • Modelo / Serial
    4P¿226813; 4P¿226815; 4P-226817; 4P-226818; 4P¿226819; 4P-226820; 4P-226821; 4P-226822
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distributed in OK and FL.
  • Descripción del producto
    ASSY, POWER SUPPLY 130V 50HZ. This component is used with the following machines: 2008T Hemodialysis Machine, 2008K Hemodialysis Delivery Equipment, 2008 K2 Hemodialysis Delivery Equipment || 2008K@home Hemodialysis Delivery System
  • 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