Events

Retiro De Equipo (Recall) de Device Recall 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
    68519
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1976-2014
  • Fecha de inicio del evento
    2014-06-11
  • Fecha de publicación del evento
    2014-07-02
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-12-19
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128129
  • 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
    Headlamp, operating, battery-operated - Product Code HPP
  • Causa
    Led battery chargers may prematurely fail and will not charge the led battery as intended.
  • Acción
    Integra initiated a voluntary recall on June 11, 2014 to consignees that have been shipped affected product lots of Integra¿ LED Battery Chargers, Catalogue No. 90523. The written notifications were delivered to US consignees by traceable courier service and non-US consignees by traceable email or facsimile. The consignee notification: Advises them of the nature of the issue and the potential for an adverse patient consequence. Advises them to review their inventory and how to determine if they have affected battery chargers. Advises them to immediately stop the use or distribution of any affected product lot numbers they may have. Requests they identify and report to Integra if they do or do not have any unexpired affected product lots. Advises them replacements battery chargers will be shipped for any affected products they affirm are in their possession and how to return their affected product. Questions regarding these instructions, please contact Integra Customer Service at 1-800-431-1123 or your Integra sales

Device

Device Recall Integra
  • Modelo / Serial
    Lot Numbers:  IE123610, IE123710, IE123810, IE123910, IE124010, IE124110, IE124210, IE124310, IE124410, IE124510, IE124610, IE124710, IE124810, IE124910, IE125010, IE125110, IE125210, IE130110, IE130210, IE130310, IE130410, IE130510, IE130610, IE130710, IE130810, IE130910, IE131010
  • Clasificación del producto
    Ophthalmic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Nationwide and the countries of Canada, Australia, Arab Emirates, Denmark, Germany, Great Britain, India, Ireland, Israel, Japan, Kuwait, Lebanon, Malta., Netherlands, Panama, Poland, Saudi Arabia, Singapore, South Africa, Spain, Sweden, and Tunisia.
  • Descripción del producto
    Integra¿ LED Battery Charger, Single Bay. || Product Number: 90523 || The LED Headlight System Battery Charger (90523) is an accessory to the LED Headlight System: || 90520US - LED Headlight w/Battery & AC/DC Power Supply - US || 90520EU - LED Headlight w/Battery & AC/DC Power Supply - EU || 90520UK - LED Headlight w/Battery & AC/DC Power Supply - UK || 90520AU - LED Headlight w/Battery & AC/DC Power Supply - AU || Product Usage: The Integra LED Headlight System Is designed to provide illumination to aid visualization during minor surgical, diagnostic, or therapeutic procedures
  • Manufacturer
    Integra LifeSciences Corp.

Manufacturer

Integra LifeSciences Corp.