Events

Retiro De Equipo (Recall) de Neotrode, Softrade, TruLink

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
    57827
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1493-2011
  • Fecha de inicio del evento
    2010-09-23
  • Fecha de publicación del evento
    2011-03-02
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-10-28
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97513
  • 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
    ecg electrode - Product Code DRX
  • Causa
    Poor signal or loss of signal. certain recalled devices have a loose wire attachment that may lead to intermittent or poor signal quality.
  • Acción
    ConMed Corporation distributed an Urgent Device Recall notification letter on Tru-Link ECG Electrode (Neonatal Pre-wired) dated September 23, 2010. ConMed Corp. has advised to cease the use of the devices immediately and conducted a recall to the user level. Direct consignees were asked to contact sub-accounts if recalled devices were further distributed and notified them of such recall. Recalled devices were to return to ConMed Corp. at 525 French Road, Utica, NY 13502 with completed Attachment II to indicate the amount returned. Customers with no recalled devices were asked to fill out Attachment II and faxed to 315-624-3225. Questions can be directed to Ms. Patricia Cotter, ConMed Recall Coordinator at 315-624-3237 or fax to 315-624-3225 or email to neorecall@conmed.com.

Device

Neotrode, Softrade, TruLink
  • Modelo / Serial
    Neotrode, Wire Attached (Catalog Number: 1731-003) Lot Code: 0904014 thru 1008134; Neotrode II, Wire Attached (Catalog Number: 1741-003) Lot Code: 0904014 thru 1008114; Softrace Limb Band (Catalog Number: 2310-003) Lot Code: 0904014 thru 1008274; Softrace Neonatal, Wire Attached (Catalog Number: 2321-003) Lot Code: 0904014 thru 1007234; Softrace Pediatric, Wire Attached (Catalog Number: 2331-003) Lot Code: 0904014 thru 1007214; and TRU-LINK ECG Electrodes (Neonatal Pre-Wired) (Catalog Number: 685-0037-00) Lot Code: 0904014 thru 1007064
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution, including USA, Dubai, Ecuador, Egypt, Germany, Holland, Indonesia, Israel, Italy, Jamaica, Kenya, Korea, Lithuania, Malaysia, Mexico, New Zealand, Norway, Qatar, Saudi Arabia, Singapore, South Africa, Sweden, Switzerland, US Virgin Islands, Canada and Belgium.
  • Descripción del producto
    Neotrode Wire Attached, Catalog Number: 1731-003; Neotrode II Wire Attached, Catalog Number: 1741-003; Softrace Neonatal Wire Attached, Catalog Number: 2321-003; Softrace Pediatric Wire Attached, Catalog Number: 2331-003; Softrace Limb Band, Catalog Number: 2310-003; TRU-LINK ECG Electrode (Neonatal Pre-Wired), Catalog Number: 685-0037-00; for use with electrocardiographic monitoring equipment to detect neonatal/pediatric heart action voltages.
  • 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