Events

Retiro De Equipo (Recall) de Device Recall BREG Cold Therapy Combination Units

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 Breg 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
    64177
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0803-2013
  • Fecha de inicio del evento
    2013-01-14
  • Fecha de publicación del evento
    2013-02-12
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-07-01
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115498
  • 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
    Pack, hot or cold, water circulating - Product Code ILO
  • Causa
    The recall was initiated because breg has determined that some sterile polar pads products manufactured from january 2010 to october 2012 may have sustained damage to the product packaging which may compromise product sterility assurance.
  • Acción
    The firm, BREG, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated January 14, 2013 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately examine your inventory and quarantine the product; complete the Return Response Form by email, Fax or mail; and contact Breg for a Return Authorization for the affected product and request replacement by contacting Breg Customer Care at 800-321-0607. Note: response is required even if you have no affected inventory. Should you have any questions regarding this communication or need to report an adverse event, please contact Breg Customer Care at 800-321-0607.

Device

Device Recall BREG Cold Therapy Combination Units
  • Modelo / Serial
    Affected product will be identified by date of manufacture from January 2010 through October 2012.
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-USA (nationwide) and the countries of Australia, Singapore, Chile, Latvia.
  • Descripción del producto
    BREG Cold Therapy Combination Units containing Sterile Polar Pads. 02356 Rev M, PAD M/U XL STER, Mfg.Date: 112012. Model #s: 10903, 10703, 09101, 09111, 09131, 09731, 09611, 09621, and 09631. Local anesthetic effect.
  • Manufacturer
    Breg Inc

Manufacturer

Breg Inc