Events

Retiro De Equipo (Recall) de Device Recall CORTRAK 2 Nasogastric/Nasointestinal (NG/NI) Feeding Tubes w/ ANTIIV Connector

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
    79479
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1277-2018
  • Fecha de inicio del evento
    2017-12-13
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162433
  • 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
    Filter, infusion line - Product Code FPB
  • Causa
    The transmitting stylet within cortrak* 2 nasogastric/nasointestinal (ng/ni) feeding tubes with anti-iv* connector (product code 20-9551trak2a) may be visible within the window of the exit port of the feeding tube. based on specifications, the transmitting stylet in the ng tube should not be visible within the port window.
  • Acción
    The firm, Halyard, sent an "URGENT: Product Advisory Notice" letter dated 12/13/2017 to its customers on about 12/13/2017. The letter described the product, problem and actions to be taken. The Customers were instructed to do the following: Instructions for distributors included to examine unsold inventory for impacted lots, complete and return the Distributor Product Advisory Notice Acknowledgement Form, and send the attached End-User/Customer Product Advisory Notice and Acknowledgement Form to all end user customers who would have potentially received impacted product by email to: monica.king@hyh.com or by FAX to: 678-254-0347. A Halyard Customer Service Representative will contact the distributors if affected product was on hand. Instructions for End-User/Customers included to evaluate the clinical facility's unused inventory for impacted lots, inform all clinicians in the facility who may use potentially impacted devices to verify that the stylet tip is not visible within the window of the exit port after engaging the stylet with the port connector of the NG/NI Feeding Tube, and if it is visible, do not use the device. Additionally they were asked to complete and return the Product Advisory Notice Acknowledgement Form by email to: monica.king@hyh.com or by FAX to: 678-254-0347. If you require further assistance, please call Halyard Regulatory Affairs at 678-477-4165. You may also contact Halyard Customer Service at 1-844-HALYARD (1-844-425-9273, OPTION 1, OPTION 3).

Device

Device Recall CORTRAK 2 Nasogastric/Nasointestinal (NG/NI) Feeding Tubes w/ ANTIIV Connector
  • Modelo / Serial
    Product code 20-9551TRAK2A, Lot No. 7909, 7839, 7876.
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution: US (nationwide) to states of: AR, CA, CO, GA, IA, LA, MI, MN, NM, TX; and country of Germany. Distributed internationally to Germany.
  • Descripción del producto
    CORTRAK* 2 Nasogastric/Nasointestinal (NG/NI) Feeding Tubes with Electromagnetic Transmitting Stylet and CORFLO* Enteral Feeding tube, ANTI-IV* Connector, 10 Fr, 140 cm || The device is used in patients that require intermittent or continuous tube feedings via the nasogastric or nasoenteric route.
  • Manufacturer
    Halyard Health, Inc

Manufacturer

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