Events

Retiro De Equipo (Recall) de Integra

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
    69541
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0491-2015
  • Fecha de publicación del evento
    2014-12-01
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-05-27
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=130891
  • 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
    Instrument, ultrasonic surgical - Product Code LFL
  • Causa
    Some specific lots of selector tubing may potentially leak irrigation fluid during use if not placed on the selector handpiece in a specific manner.
  • Acción
    Integra sent an 'Urgent- Medical Device Correction' letters/acknowledgement forms dated 9/29/2014 by traceable courier service. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review their inventory for the affected product, complete the attached form. Complete the other information on the form and return the form by email or fax. Customers with questions should contact Customer Service at 1-855-532-1723.

Device

Integra
  • Modelo / Serial
    Lot Numbers: 130849;1132912;1132913;1132914;1133101;1133102;1133103;1133104;1133105;1133495;1134005;1134006;1134007;1134120;1134121;1134122;1134124;1134126;1134128;1134130;1134131;1134132;1134133;1134620;1134621;1134669;1134670;1134671;1134671;1134694;1134695;1140357;1141561;1141562;1141645;1141754;1141563;1141564;1141647;1142352;1142353;1142409; & 1142410
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) and Internationally to Algeria, Australia, Bulgaria, Canada, Germany, Great Britain, Greece, Hungary, Indonesia, Israel, Italy, Japan, Mexico, Portugal, Spain, Sweden, Thailand, Turkey, and Wales.
  • Descripción del producto
    Integra Selector Kit || Sterile single use device A bi-lumen, sterile single use accessory used for the Selector Integra Ultrasonic Surgical Aspirator system. One of the tubing lumen transmits irrigation fluid from the console to the handpiece of the system, and the other tubing lumen transmits aspirated fluid and tissue back to the system console. The aspirator is intended to be used to facilitate the removal of cellular and other unwanted soft tissue. The system provides selective tissue disintegration with simultaneous irrigation and aspiration. The system has been designed for use by surgeons in the areas of neurosurgery and gastroenterology including laparoscopic procedures. Its use in other procedures is regarded as experimental and is thus subjecto to appropriate local regulatory approval
  • Manufacturer
    Integra LifeSciences Corp.

Manufacturer

Integra LifeSciences Corp.