Events

Retiro De Equipo (Recall) de Device Recall Straight Ventricular Catheter

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
    75065
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2905-2016
  • Fecha de inicio del evento
    2016-08-23
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-03-29
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149270
  • 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
    Shunt, central nervous system and components - Product Code JXG
  • Causa
    During final sampling inspection, one of the lots was discovered with a total incomplete packaging seal of the sterile product.
  • Acción
    Integra sent an "Urgent Voluntary Medical Device Recall" Letter and Recall Acknowledgement and Return Form dated August 23, 2016 to their affected customer. The letter identified the product, the problem, and the action to be taken by the customer. The customer was advised if they have distributed the product to identify those customers and forward a copy of the enclosed Integra Medical Device Voluntary Recall Notification to those customers. The customer was also asked to review their inventory for the affected product and complete the attached form indicating whether or not they have any of the affected product in their inventory. Customers with questions were instructed to contact Customer Service at 1-800-654-2873.

Device

Device Recall Straight Ventricular Catheter
  • Modelo / Serial
    Catalog Number VC-1, Lot #0195451 with expiry 05/2019
  • Clasificación del producto
    Neurological Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide Distribution to KS only
  • Descripción del producto
    Integra Straight Ventricular Catheter F8, 25 cm, Sterile EO, Rx only, packaged in a Tyvek pouch and secondary packaged in to Tyvek pouch, sealed in a cardboard box. || Silicone elastomer Ventricular Catheter for use with hydrocephalus valves
  • Manufacturer
    Integra LifeSciences Corp.

Manufacturer

Integra LifeSciences Corp.