Retiro De Equipo (Recall) de Device Recall TruChoice Adjustable Vent Valve

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 Alliant Enterprises 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
    Cpb check valve, retrograde flow, in-line - Product Code MJJ
  • Causa
    The firm is initiating this recall due to the receipt of 2 complaints of malfunction of the joint holding the 2 halves of the vent valve together.
  • Acción
    Alliant Healthcare sent an URGENT: MEDICAL DEVICE RECALL letter on 7/21/2011 and 7/25/2011. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately review the recall notification and quarantine any affected product. If product was further distributed, customers were to forward the letter with the Recall Return Response Form immediately to all affected locations and indicate which locations on the Recall Return Response Form. Customers were also instructed to discontinue use immediately, dispose of the affected product per their normal disposal protocol, and fax the Recall Return Response Form to Alliant Healthcare Products at 269-629-5770. Upon receipt of the Recall Return Response Form, a substitute vent valve (non-adjustable only) will be sent to their location for each affected product for which disposal has been properly documented in writing. For questions call 269-629-0300, ext 226.


  • Modelo / Serial
    Lot # 2013-04-05 thru 2013-09-22
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Worldwide Distribution - USA including Michigan, Tennessee, New York, and California and the countries of Chile and Korea
  • Descripción del producto
    TruChoice Alliant Healthcare Products, REFERENCE# SSD-100EX, QUANTITY: 25, DESCRIPTION: TUBING W/ ONE WAY VALVE, STERILE || The TrueChoice Vacuum Control One-Way Vent Valve is indicated for use during cardiopulmonary bypass surgery to help prevent the buildup of excess vacuum pressure when suctioning either from the heart or the surgical field, and to help prevent inadvertent retrograde flow and air to the heart.
  • Manufacturer


  • Dirección del fabricante
    Alliant Enterprises LLC, 8850 M 89, Richland MI 49083-8558
  • Empresa matriz del fabricante (2017)
  • Source