Events

Retiro De Equipo (Recall) de VISTA Negative Pressure Wound Therapy Charger

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 Smith And Nephew, Inc. Wound Management Division.

¿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
    49566
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0162-2009
  • Fecha de inicio del evento
    2008-08-07
  • Fecha de publicación del evento
    2008-10-27
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2009-10-01
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73818
  • 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
    Battery Charger - Product Code BTA
  • Causa
    External battery chargers used with the version 29 vista negative pressure wound therapy pumps are failing to properly charge the pump's battery.
  • Acción
    Each consignee was notified by recall letter (Field Correction Notification) dated 8/7/08 via FEDEX overnight. Within five (5) working days of the date of the customer notification a Smith & Nephew representative will contact the customers to assess their inventory and schedule delivery of replacement battery chargers. Contact Smith & Nephew, Inc. (Customer Care Center) at 1-800-876-1261 for for assistance.

Device

VISTA Negative Pressure Wound Therapy Charger
  • Modelo / Serial
    SSN: RoHS02492601 Last 4 digits of SSN identifies affected products: 05/08; 06/08; 07/08; 08/08; 09/08; 10/08; 11/08; 12/08; 13/08; 14/08 and 15/08.
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide within U.S. and internationally to United Kingdom, New Zealand, Germany, Canada and Australia.
  • Descripción del producto
    GlobTek, Inc. Power Supply for Medical Use Part No: TR9CE4000LCP-Y-MED MODEL: GTM21097-5012, Made in China. || Indicated for patients who would benefit from a suction device particularly as the device may promote wound healing, including patients who would benefit from vacuum assisted drainage and removal of infectious materials or other fluid from wounds under the influence of continuous pressure.
  • Manufacturer
    Smith And Nephew, Inc. Wound Management Division

Manufacturer

Smith And Nephew, Inc. Wound Management Division
  • Dirección del fabricante
    Smith And Nephew, Inc. Wound Management Division, 11775 Starkey Road, Largo FL 33773-4727
  • Empresa matriz del fabricante (2017)
    Smith & Nephew plc
  • Source
    USFDA