Events

Retiro De Equipo (Recall) de Device Recall INTEGRA NEUROSCIENCESSuture CollarsNon Sterile for Single Use Only

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 Neurosciences PR, 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
    60599
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1049-2012
  • Fecha de inicio del evento
    2011-11-28
  • Fecha de publicación del evento
    2012-02-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-10-29
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106495
  • 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
    The current packaging configuration for the non-sterile shunt accessories could lead to the potential for confusion regarding product sterility.
  • Acción
    Integra sent an Urgent Product Recall Notification letter dated November 28, 2011. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to fill out and sign the attached Recall Acknowledgement Form noting the part numbers, lot numbers and quantity of the affected product in their inventory. Customers were asked to contact Integra LifeSciences Corporation International Customers Service at 609-936-5400 to arrange for Returns. If customers do not have any of the affected product in their inventory they are required to complete and sign the form and indicate they have NO affected product in their inventory. Customers should fax or email their Recall Acknowledgement Form to: 609-750-4259 or LAPAC_CS@Integralife.com For questions call 609-936-2495.

Device

Device Recall INTEGRA NEUROSCIENCESSuture CollarsNon Sterile for Single Use Only
  • Modelo / Serial
    1021597, 1031020, 1071033, 1092906, 1094646, 1100128, 1101134
  • Clasificación del producto
    Neurological Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - USA (nationwide) and the countries of Austria, Canada, Italy, Australia
  • Descripción del producto
    "***REF NL82059-02***INTEGRA NEUROSCIENCES***Suture Collars***Non Sterile for Single Use Only***Plainsboro, NJ***" || Collars for lumbar peritoneal shunt
  • Manufacturer
    Integra Neurosciences PR, Inc.

Manufacturer

Integra Neurosciences PR, Inc.
  • Dirección del fabricante
    Integra Neurosciences PR, Inc., Carr 402 Norte Km 1.2, Anasco PR 00610
  • Source
    USFDA