Events

Retiro De Equipo (Recall) de Covidien

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 Covidien LLC.

¿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
    69257
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-0043-2015
  • Fecha de inicio del evento
    2014-09-18
  • Fecha de publicación del evento
    2014-10-15
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-05-24
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=130108
  • 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
    Pacemaker, cardiac, external transcutaneous (non-invasive) - Product Code DRO
  • Causa
    Covidien medi-trace cadence and kendall defibrillation electrodes not compatible for use with philips model fr3 or frx aeds defibrillators.
  • Acción
    Covidien notified customers by letter via Federal Express on 9/18/14. The letter requests that they immediately verify that they are not stocking Covidien electrodes for use with Philips FR3 or FRx AED units. A customer reply acknowledgement form is provided to allow Covidien to track the effectiveness of the notification. Covidien is adding a label to all levels of packaging that alerts the user that the product is not compatible with the FR3 and FRx AED units. Distribution partners notified to address product in the distribution chain that is available to be relabeled. For questions customers should call (800) 962-9888, option 8, then extension 2500. For questions regarding this recall call 508-261-8000.

Device

Covidien
  • Modelo / Serial
    All lots
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribtion-USA (nationwide) including Puerto Rico and the countries of Canada Greece Israel Belgium Finland France Germany Great Britain Ireland Italy Norway Poland Portugal Spain Sweden Switzerland Brazil Chile Philippines Taiwan Australia New Zealand.
  • Descripción del producto
    Covidien Medi-Trace Cadence and Kendall Adult Multi-Function Defibrillation Electrodes, Radiotransparent || Part Number: 22660R
  • Manufacturer
    Covidien LLC

Manufacturer

Covidien LLC
  • Dirección del fabricante
    Covidien LLC, 15 Hampshire St, Mansfield MA 02048-1113
  • Empresa matriz del fabricante (2017)
    Medtronic plc
  • Comentario del fabricante
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA