Events

Retiro De Equipo (Recall) de Licox Brain PMO Probe Kit; for Cerebral Pressure, Ref IP2.P;

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 Integra LifeSciences Corp..

¿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
    56820
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0161-2011
  • Fecha de inicio del evento
    2010-09-15
  • Fecha de publicación del evento
    2010-10-28
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-04-18
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94583
  • 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
    Device, monitoring, intracranial pressure - Product Code GWM
  • Causa
    Incorrect expiration date - the outer boxes of the ip2p licox complete kit for cerebral pressure, temperature and icp monitoring probes, lot 250210a are labeled with an incorrect shelf life date (10 months too long).
  • Acción
    Integra issued Urgent Product Recall Notification letters dated September 16, 2010 to US customers and foreign consignees, identifying the affected lots and actions to be taken by customers. Affected product is not to be further distributed and should be quarantined pending return to the firm. Customers and Distribors should contact Integra Customer Service for a Returned Material Authorization Number, and then return the product to the Distribution Center. In addition, a Recall Acknowledgement and Return Form is to be completed and returned. Customers can contact Integra at 609 936-2495.

Device

Licox Brain PMO Probe Kit; for Cerebral Pressure, Ref IP2.P;
  • Modelo / Serial
    Ref IP2P, Lot number: 250210A; Serial Numbers: 833, 834, 835, 836, 837, 838, 839, 841, 844, 846, 847, 848, 850, 851, 852, 853, 854, 855, 857, 858, 859, 860, 861, 862, 864.
  • Clasificación del producto
    Neurological Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution: USA, including the states of FL, ID, IL, and NJ, and the countries of Argentina and Costa Rica.
  • Descripción del producto
    Licox Brain PMO Probe Kit; || Ref IP2.P; || Multiparameter Monitoring Oxygen + ICP Channel: Contain Products: REF IP2 Bolt kit for 2 brain probes, Ref CC1.P1 combined Oxygen & Temperature probe; || Contains sterile and non-pyrogenic if package is unopened and undamaged. || Integra US, 311 Enterprise Drive, Plainsboro, NJ 08536
  • Manufacturer
    Integra LifeSciences Corp.

Manufacturer

Integra LifeSciences Corp.