Events

Retiro De Equipo (Recall) de Device Recall Integra Camino Intracranial Pressure Monitoring Catheter with Licox IMC Bolt Fitting

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
    71343
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1815-2015
  • Fecha de inicio del evento
    2015-05-27
  • Fecha de publicación del evento
    2015-06-18
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-12-09
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=137352
  • 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
    Integra lifesciences is recalling the camino intracranial pressure monitoring catheters because they may have been incorrectly assembled. specifically, the o-ring in the bolt adapter may be in the wrong location and as a result, there is a potential csf/blood could leak from the bolt adapter.
  • Acción
    Integra sent an Urgent Medical Device Recall letter dated May 27, 2015, to all customers who received the Camino Intracranial Pressure Monitoring Catheters because they may have been incorrectly assembled. Specifically, the o-ring in the bolt adapter may be in the wrong location and as a result, there is a potential CSF/blood could leak from the bolt adapter. The letter informs the customers of the problems identified and the actions to be taken. Customers were instructed to complete the customer response form and return it by email or fax to: FCA3@integralife.com or FAX to 1-609-275-9445. Customers with any questions regarding the instructions are instructed to contact Customer Service at 1-888-601-0203. For questions regarding this recall call 609-936-6822.

Device

Device Recall Integra Camino Intracranial Pressure Monitoring Catheter with Licox IMC Bolt Fitting
  • Modelo / Serial
    305000291459, 305000299228, 305000300396, 305000301413, 305000312261, 305000315716, 30500X294240, 30500X304371, 30500X309674, 30500X318076, 3050RX285879, 3050RY297365, 305E00318970, 305E0X320986
  • Clasificación del producto
    Neurological Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US (Nationwide) and Internationally to ARGENTINA, BRAZIL, BULGARIA, CANADA, COLUMBIA, COSTA RICA, FRANCE, GERMANY, ITALY, MEXICO, GERMANY, ITALY, MEXICO, PANAMA, SOUTH AFRICA, SPAIN, SWITZERLAND, UNITED ARAB EMIRATES, AND UNITED KINGDOM
  • Descripción del producto
    Integra Camino Intracranial Pressure Monitoring Catheter with Licox IMC Bolt Fitting, Catalog No. 110-4L || The Camino Intracranial Pressure Monitoring Catheter is a sterile transducer-tipped pressure monitoring catheter with accessory items to be used as a diagnostic tool for rapidly determining and continuously monitoring intracranial pressure. The Camino catheter has a miniature transducer at the distal tip. This design eliminates the need for a fluid-filled system to carry pressure waves to an external transducer and thus, the problems inherent in such fluid-filled systems are eliminated. The Camino catheter is packaged with a zero adjustment tool which allows for the adjustment of the transducer during catheter preparation, and the LICOX Bolt Adapter Fitting. The Camino Intracranial Pressure Monitoring Catheter with Licox IMC Bolt fitting, Model 110-4L is indicated for use by a qualified Neurosurgeon when direct measurement of intracranial pressure in the parenchyma is clinically important. It is intended to be used only through a Licox Brain Oxygen Monitoring System Bolt.
  • Manufacturer
    Integra LifeSciences Corp.

Manufacturer

Integra LifeSciences Corp.