Retiro De Equipo (Recall) de Device Recall DeVilbiss Healthcare

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 DeVilbiss Healthcare LLC.

¿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
  • ID del evento
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
  • Fecha de inicio del evento
  • Fecha de publicación del evento
  • Estado del evento
  • País del evento
  • Fecha de finalización del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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
    Apparatus, suction, ward use, portable, ac-powered - Product Code JCX
  • Causa
    End users of the devilbiss disposable suction container/filter had exposed the bacterial filter cartridge to fluid, thereby occluding the filter and rendering it unusable.
  • Acción
    DeVilbiss Healthcare sent End users a field corrective action letter dated March 7, 2013, to all affected customers to reinforce the proper cleaning method. This letter is to inform you that we have come across cases where end users had exposed the bacterial filter cartridge in the disposable suction container to fluid, thereby occluding the filter and rendering it unusable Specifically what do you have to do when you receive a correction/recall notice? " The US FDA states in its correction/recall regulations that: "Consignees that receive a recall communication should immediately carry out the instructions set forth by the recalling firm and, where necessary, extend the recall to its consignees." "Enclosed you will find two Urgent Medical Device Correction letters addressed to DeVilbiss Dealer/Provider" and "DeVilbiss User" that we ask you read carefully. "It is important that you follow the actions outlined in these letters to ensure we can effectively disseminate this information to end-users. "To reach your direct accounts we ask that you send a copy of the "DeVilbiss User" letter to each of these end-users. We sincerely appreciate all of your efforts to ensure the safety of your customers that depend on DeVilbiss products. We thank you in advance for your assistance and apologize for any inconvenience that you may experience as a result of this situation. Should you have any questions or concerns, please contact DeVilbiss Healthcare Customer Service at 1-800-338-1988.


  • Modelo / Serial
    Part Number 7305D-634 with model numbers 7305D-632, 7305D-633, and 7305D-633-25
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Worldwide Distribution - USA and the countries of Mexico and Canada.
  • Descripción del producto
    DeVilbiss Vacu-Aide QSU Suction Unit (Disposable Suction Container/Filter), 800 ML DISP Container, Unassembled, 800 ML DISP Container w/6' patient tubing, and 800 ML DISP Container w/6' patient tubing, assembled. || DeVilbiss Vacu-Aide QSU Suction Unit (Disposable Suction Container/Filter) is used to remove fluids from the airway or respiratory support system and infectious materials from wounds. It is available for use by consumers by physician order.
  • Manufacturer


  • Dirección del fabricante
    DeVilbiss Healthcare LLC, 100 Devilbiss Dr, Somerset PA 15501-2125
  • Empresa matriz del fabricante (2017)
  • Source