Events

Retiro De Equipo (Recall) de Device Recall PadPro(R) Adult Radiotransparent Multifunction 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
    65112
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1317-2013
  • Fecha de inicio del evento
    2013-05-03
  • Fecha de publicación del evento
    2013-05-13
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-08-25
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117902
  • 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
    Automated external defibrillators (non-wearable) - Product Code MKJ
  • Causa
    Conmed was notified by the contract manufacturer that their wire/connector supplier reported damage to the connector tooling which could pinch or compress the lead wire filaments and potentially render the device incapable of delivering the appropriate energy or shock to the patient and/or could cause potential injury to user or patient.
  • Acción
    ConMed sent a URGENT: Field Safety Notice letter dated May 3, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to please review your inventory for any of the devices listed on Attachment I. Business Reply Forms were sent to the domestic and foreign consignees on May 3, 2013. The domestic notices were mailed by USP Priority Mail pouches. The recall is being conducted to the end user level. We ask that you contact all of those organizations within your 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 call 1 315-624-3237 or fax to +1 315-624-3225.

Device

Device Recall PadPro(R) Adult Radiotransparent Multifunction Electrodes
  • Modelo / Serial
    Lot Code Y092012-21, Manufacture Date 10/10/2012;  Lot Code Y102612-12, Manufacture Date 11/17/2012; Lot Code Y110912-20, Manufacture Date 11/30/2012; Lot Code Y112912-10, Manufacture Date 12/22/2012; Lot Code Y121312-19, Manufacture Date 01/03/2013; Lot Code Y011013-13, Manufacture Date 01/29/2013; Lot Code Y012513-02, Manufacture Date 02/12/2013;  Lot Code Y020713-05, Manufacture Date 02/26/2013; Lot Code Y021413-03, Manufacture Date 03/07/2013; Lot Code Y030113-04, Manufacture Date 03/23/2013
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA (nationwide) and the country of: Saudi Arabia.
  • Descripción del producto
    PadPro(R) Adult Radiotransparent Multifunction Electrodes, REF/Catalog No. 2001M-C. || The PadPro(R) Adult Radiotransparent Multifunction Electrodes with Carbon Leadwires and Medtronic(R) Connector are intended to be used in external pacing, defibrillation and monitoring applications
  • Manufacturer
    ConMed Corporation

Manufacturer

ConMed Corporation
  • Dirección del fabricante
    ConMed Corporation, 525 French Road, Utica NY 13502
  • Empresa matriz del fabricante (2017)
    CONMED Corp.
  • Source
    USFDA