Events

Retiro De Equipo (Recall) de Device Recall MAQUET Servo Humidifier 163

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 Teleflex, 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
    70127
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-1008-2015
  • Fecha de inicio del evento
    2014-12-04
  • Fecha de publicación del evento
    2015-02-06
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-03-21
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132281
  • 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
    Condenser, heat and moisture (artificial nose) - Product Code BYD
  • Causa
    Connector mount cracks which may lead to a leak failure during use and necessitate immediate replacement in the breathing circuit. if leak exists and is left untreated, patient may be deprived of adequate anesthetic gases over a period of time and serious adverse health consequences may occur.
  • Acción
    An Urgent - Field Safety Notice, dated December 4, 2014, was sent to end users that identified the product, problem, and action to be taken. Customers were requested to immediately check inventory, discontinue use and distribution, quarantine. Customers were to return the Acknowledgement form and request a return authorization number from their local Maquet representative for affected devices. A credit will be issued upon receipt of the returned affected product. For questions or for support concerning this issue, a local Maquet representative should be contacted at fieldactions@maquet.com.

Device

Device Recall MAQUET Servo Humidifier 163
  • Modelo / Serial
    Batch Numbers: 201321, 201323, and 201324.
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Distributed in the states of FL, MI, WV, and KS.
  • Descripción del producto
    MAQUET Servo Humidifier 163; Model No.: 01-06-8125-8, catalog no. XKC01-06-8125-8. || A heat and moisture condenser (artificial nose) is a device intended to be positioned over a tracheotomy (a surgically created opening in the throat) or tracheal tube (a tube inserted into the trachea) to warm and humidify gases breathed in by a patient.
  • Manufacturer
    Teleflex, Inc.

Manufacturer

Teleflex, Inc.
  • Dirección del fabricante
    Teleflex, Inc., 550 E Swedesford Rd Ste 400, Wayne PA 19087-1601
  • Empresa matriz del fabricante (2017)
    Teleflex Incorporated
  • Source
    USFDA