Events

Retiro De Equipo (Recall) de Device Recall ThermoGard Dual Dispersive Electrodes

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 Conmed Corporation.

¿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
    73607
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2598-2016
  • Fecha de inicio del evento
    2016-05-18
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2018-05-24
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=146783
  • 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
    Electrosurgical, Cutting & Coagulation & Accessories - Product Code GEI
  • Causa
    A version of the dual dispersive electrodes may not be compatible with some electrosurgical generators, placing patients at risk for undetected pad lift and a potential burn.
  • Acción
    On May 17, 2016 CONMED Corporation distributed Urgent Device Recall notification letters and Business Reply Forms to their customers via courier service. CONMED Corporation has decided to recall these ThermoGard¿ Dual Dispersive Electrodes for all customers who do not use an electrosurgical generator that employs the Contact Quality Monitoring systems listed. If your electrosurgical generator is not listed, your generator should not be used with the lot codes of the ThermoGard Dual Dispersive Electrodes identified. Customers are advised to inspect inventory for any of the recalled devices. If you use the ThermoGard¿ Dual Dispersive Electrodes in conjunction with an electrosurgical generator listed, no further action is required. However, if your electrosurgical generator and CQM system is not listed above, do not use the affected lot codes of ThermoGard¿ Dual Dispersive Electrodes. Please note that ThermoGard¿ Dual Dispersive Electrodes produced after July 5, 2015, are not subject to this recall. Customers should contact all of those departments or organizations within their facility and any other facilities that you may have supplied or given these affected products to. It is imperative that all end users of these devices receive this notice and respond immediately. If you have questions, please contact Patricia Cotter, CONMED Recall Coordinator 315-624-3237 (8AM-5PM EST, M-F) or fax to 315-624-3225 or email thermog@CONMED.com.

Device

Device Recall ThermoGard Dual Dispersive Electrodes
  • Modelo / Serial
    Beginning Lot Code 141001X with Ending Lot Code 20150705X.
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- USA, including AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, & Puerto Rico; and, the countries of Australia, Canada, Belgium, Brunei Darussalam, China, France, Guatemala, Hong Kong, Israel, Italy, Japan, South Korea, Malaysia, Mexico, New Zealand, Norway, Portugal, Saudi Arabia, Spain, Sweden, and United Arab Emirates.
  • Descripción del producto
    Pediatric Dual Dispersive Electrodes (for patients 5-15 kg.), use with the Birtcher Pad Sensing System (PSS) on the Birtcher Systems 6000, 6400, 6500 and CONMED Systems 7500 and 7550 ABC¿ generators or conventional electrosurgery units with similar contact monitoring systems, 10' (3.05m) Cable, Catalog Number 7-383. || Intended to be used for the dispersion and return to the electrosurgical generator.
  • Manufacturer
    Conmed Corporation

Manufacturer

Conmed Corporation
  • Dirección del fabricante
    Conmed Corporation, 310 Broad St, Utica NY 13501-1203
  • Empresa matriz del fabricante (2017)
    CONMED Corp.
  • Source
    USFDA