Events

Retiro De Equipo (Recall) de Device Recall Concha Therm Neptune Heated Humidifier

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 Telefelx Medical.

¿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
    54232
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1040-2010
  • Fecha de inicio del evento
    2010-01-12
  • Fecha de publicación del evento
    2010-03-09
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-04-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=87913
  • 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
    humidifier - Product Code BTT
  • Causa
    When turned on, the neptune heater may cause an artifact on the patient's heart monitor.
  • Acción
    Teleflex consignees were notified via Urgent Medical Device Recall letter via next day delivery on/about 01/12/2010. They were asked to return all of the affected product. Each consignee that is a distributor was instructed to forward the letter to their consignees to retrieve relevant product from those locations. A second mailing to non-responders on the consignee list will be made approximately four to six weeks after the first mailing. A third mailing to non-responding customers on the consignee list will be made approximately four to six weeks after the second mailing or as an alternative, they may be contacted by phone, e-mail or fax. A record of these contacts will be maintained. Affected products received by Teleflex Medical will be reworked with software upgrade and placed back into distribution. Consignees will either receive a software upgrade on site by a third party or replacement product with the software upgrade. Records will be maintained accordingly.

Device

Device Recall Concha Therm Neptune Heated Humidifier
  • Modelo / Serial
    Product numbers: 425-00, 425-10 and 525-30, All lot and serial numbers.
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    U.S. Canada, India, Japan, Puerto Rico, Germany, France, Italy and Ireland.
  • Descripción del producto
    Teleflex Medical, Hudson RCI, Concha Therm Neptune, Heated Humidifier. Product numbers: 425-00, 425-10 and 525-30.
  • Manufacturer
    Telefelx Medical

Manufacturer

Telefelx Medical
  • Dirección del fabricante
    Telefelx Medical, 2917 Weck Drive, Durham NC 27709
  • Empresa matriz del fabricante (2017)
    Teleflex Incorporated
  • Source
    USFDA