Events

Retiro De Equipo (Recall) de Device Recall ProventSR or Provent50

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 Ventus Medical, 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
    61129
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-1033-2012
  • Fecha de inicio del evento
    2012-02-03
  • Fecha de publicación del evento
    2012-02-15
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-02-15
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107359
  • 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
    Expiratory resistance valve, intranasal, for obstructive sleep apnea - Product Code OHP
  • Causa
    A discrepancy was found during inspection of a returned unit that the lot number and sku on cartoon did not match.
  • Acción
    Ventus Medical sent a Urgent Medical Device Correction Letter dated February 3, 2012, to all affected customers. The letter identified the problem, the product and the action needed to be taken by the customer. There is no health hazard associated with the affected devices or with the continued use of the affected devices. Ventus Medical wanted Customers to be aware of the problem so they can respond to patients if inquiries are received. A sample letter to patients was also provided, should physicians choose to provide it to patients. Questions may be directed to Ventus Medical Territory Business Manager at 650-632-4199.

Device

Device Recall ProventSR or Provent50
  • Modelo / Serial
    Catalog number MRS0227; Lot number: 14261182.
  • Clasificación del producto
    Dental Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution including the states of OH, TX, IL, OR, CA, FL and NY.
  • Descripción del producto
    Provent -SR - Sleep Apnea Therapy-SR (standard resistance). || Prescription only, Single Use; || Packed 30 units per box || Manufactured in the USA by Ventus Medical Inc. || 1301 Shoreway Road, Suite 425; || Belmont, CA 94002 || Used in the treatment of obstructive sleep apnea.
  • Manufacturer
    Ventus Medical, Inc.

Manufacturer

Ventus Medical, Inc.
  • Dirección del fabricante
    Ventus Medical, Inc., 1301 Shoreway Rd Ste 425, Belmont CA 94002-4154
  • Empresa matriz del fabricante (2017)
    Ventus Medical Inc.
  • Source
    USFDA