Events

Retiro De Equipo (Recall) de KimVent

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 Halyard Health, 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
    71110
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1678-2015
  • Fecha de inicio del evento
    2015-04-14
  • Fecha de publicación del evento
    2015-05-26
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-07-07
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=136144
  • 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
    Catheters, suction, tracheobronchial - Product Code BSY
  • Causa
    The internal blue flapper valve of certain kimvent turbo-cleaning closed suction system for adults may have a potential defect. if present, the defect potentially allows air to leak out of the closed ventilator circuit.
  • Acción
    Halyard Health Regulatory Affairs sent an Urgent Voluntary Product Recall letter dated April 16, 2015, to all affected consignees. Consignees were instructed to quarantine and discontinue use of the recalled product. Specific return instructions were provided in the Notice. The consignees were also requested to provide a response to to the recall notification. Wholesalers were instructed to follow their internal recall procedures to identify and address affected products. Consignees with questions were instructed to call Halyard Health Regulatory Affairs at 470-448-5700.

Device

KimVent
  • Modelo / Serial
    M5019T311, M4335T317, M5034T317, M5040T311 & M5005T303
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution including CA, MA, MI, NC, TX, VA , and WA.
  • Descripción del producto
    KimVent Turbo-Cleaning Closed Suction System for Adults, 10 F T-Piece (Product Code 227105); KimVent Turbo-Cleaning Closed Suction System for Adults, 12 F, DSE (Product Code 2271603); KimVent Turbo-Cleaning Closed Suction System for Adults, 12 F, T-Piece (Product Code 227135).
  • Manufacturer
    Halyard Health, Inc

Manufacturer

Halyard Health, Inc
  • Dirección del fabricante
    Halyard Health, Inc, 5405 Windward Pkwy, Alpharetta GA 30004-3894
  • Source
    USFDA