Events

Retiro De Equipo (Recall) de Device Recall Integra NeuroSciences Combo Kit

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
    58490
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-2194-2011
  • Fecha de inicio del evento
    2011-02-22
  • Fecha de publicación del evento
    2011-05-13
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-05-13
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99461
  • 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
    Drills, burrs, trephines & accessories (manual) - Product Code HBG
  • Causa
    Outer packaging of combo kit was mislabeled with an incorrect lot number.
  • Acción
    Integra LifeSciences Corp. sent a " Urgent Product Recall Notification" letter dated February 22, 2011, to the only affected consignee. It was reported the Combo Kits of SPOO98 / INS- 4500 ( Hermetic Large Style Ventricular Catheter set and drill set for NY) - Catalog # 31046 Lot Number 171237, Outer packages were labeled incorrectly. The customer was advised to return this, and they would be replaced with correctly labeled product. The issue is easily recognizable, and does not pose a safety risk to patients. An acknowledgement form was included to be returned to Integra. Further information is available at 609-936-2485.

Device

Device Recall Integra NeuroSciences Combo Kit
  • Modelo / Serial
    Lot 171237
  • Clasificación del producto
    Neurological Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution -- including the state of New York.
  • Descripción del producto
    Integra NeuroSciences, Combo Kit, Lot 171237, Integra LifeSciences 3498 West 2400 South, West Valley City, UT 84119. || A kit for cranial access containing multiple necessary components to create the burr hole which is used to gain access to the cranial vault for the purpose of providing a portal for catheter placement.
  • Manufacturer
    Integra LifeSciences Corp.

Manufacturer

Integra LifeSciences Corp.