Events

Retiro De Equipo (Recall) de INTELLIFLO DRESSING

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, An Orthofix Company.

¿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
    58247
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2326-2012
  • Fecha de inicio del evento
    2010-08-11
  • Fecha de publicación del evento
    2012-09-06
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-09-06
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98803
  • 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
    Tape and bandage, adhesive - Product Code KGX
  • Causa
    This recall has been initiated due to confirmation that the polar dressing, knee/mu/shldr intelli-flo-breg does not meet the required thickness as specified. the dressing in the sterile pouch measures a thickness of 0.010" instead of 0.020". this change in thickness makes the dressing thinner, less durable and subject to tearing. the product is mislabeled.
  • Acción
    The firm, Breg Orthofix, called their customers on August 11, 2010 sent a letter dated August 12, 2010 and emails to all customers. The call and letter described the product, problem and actions to be taken. The customers were instructed to take immediate action to identify and quarantine the product at their facility. Breg established a return materials authorization and is contacting their customers to provide a Return Authorization to return the dressings. Breg is also providing replacement dressings. If you have any questions regarding communication or the Intelli-Flo Sterile Dressing, contact Breg Customer Relations at (800) 321-0607.

Device

INTELLIFLO DRESSING
  • Modelo / Serial
    Lot # D101564
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA (nationwide) and country of: Nova Scotia.
  • Descripción del producto
    Polar Dressing, Knee/MU/Shldr Intelli-Flo-Breg, PN 10630 || Used with cold therapy pads to provide insulation barrier between the pad and patient's skin.
  • Manufacturer
    Breg Inc, An Orthofix Company

Manufacturer

Breg Inc, An Orthofix Company