Events

Retiro De Equipo (Recall) de Device Recall CORE Trumpet Handpiece only

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
    74774
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0135-2017
  • Fecha de inicio del evento
    2016-06-27
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2018-06-07
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148418
  • 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
    Catheter, peritoneal - Product Code GBW
  • Causa
    The packaging seal may contain a crease. the crease may result in an open channel. these channels may compromise sterility of the product.
  • Acción
    ConMed sent an Urgent Device Recall letter dated June 27, 2016, to all affected customers with reply forms via USP First Class Mail. International customers received a notice dated July 11, 2016 by courier service. Customers were advised to inspect their inventory for any of the devices subject to recall. Customers were urged to contact all departments within their facility and any other facilities within their organization that may have received affected products. It is imperative that all end users of these devices receive the notification. Customers who have received any of the affected product are asked to complete and return the reply form along with the device to: CONMED Corporation 525 French Road Utica, NY 13502 USA Attn: Ed Kovac. Please do not return used devices. Replacement product will be issued unless otherwise requested. If customers do not have any affected devices to return, complete and return the business reply form indicating they have no devices and return by one of the means listed:1. Email to: coresihp@conmed.com 2. Fax to: Field Action Support Team at 315-624-3225. 3. US mail, using enclosed postage-paid envelope, to: CONMED, 525 French Road, Utica, NY 13502; Attn: Field Action Support Team. Customers with questions or requests, should contact the Field Action Support Team at 315-624-3237, fax to 315-624-3225, or email coresihp@conmed.com.

Device

Device Recall CORE Trumpet Handpiece only
  • Modelo / Serial
    Beginning Lot Code 110609X to Ending Lot Code 20160308X
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US (Nationwide) Internationally: to Australia, Austria, Uruguay, Denmark, Germany, Ireland, Italy, United Kingdom, Guatemala, Czech Republic & Canada.
  • Descripción del producto
    CORE¿ Trumpet Handpiece only, Catalog Number CD8450 || The CORE Trumpet (CD81XX, CD83XX, and CD84XX) has applications in gynecological laparoscopy, laparoscopic cholecystectomy and other laparoscopic procedures
  • Manufacturer
    ConMed Corporation

Manufacturer

ConMed Corporation
  • Dirección del fabricante
    ConMed Corporation, 525 French Rd, Utica NY 13502-5945
  • Empresa matriz del fabricante (2017)
    CONMED Corp.
  • Source
    USFDA