Retiro De Equipo (Recall) de Device Recall Edwards Lifesciences Ergonic Double Acting DeBakey Forceps with Narrow Straight Tip

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 Edwards Lifesciences, 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
  • ID del evento
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
  • Fecha de inicio del evento
  • Fecha de publicación del evento
  • Estado del evento
  • País del evento
  • Fecha de finalización del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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
    Forceps - Product Code HTD
  • Causa
    Edwards lifesciences is recalling one lot of ergonic instrument due to mislabeling. ergonic scissors standard curved labeled as a double acting debakey forcep. edwards control confirmed that the laser etching on the device was incorrect.
  • Acción
    Edwards sent an " Urgent Field Safety Notice" to all affected customers dated November 20, 2013. The letter identified the product the problem and the action needed to be taken by the customers. Action to be taken by user: Our records show that you received one of these instruments. Our sales representative will be on-site to remove this instrument and provide a replacement. Please assist our sales representative in reviewing your entire inventory for the instrument listed in the recall letter. The form has been pre-populated with the inventory from our records. If you have additional inventory of this affected lot within your control, please add the quantity to the section on the form provided. Please remove the instrument from use, quarantine the device at your site and support the Edwards Sales Representative to return this product to Edwards. An acknowledgment form is included to assist you in the assessment of your inventory. While our sales representative is on-site, please complete the attached acknowledgment form and fax it back to Edwards Customer Service at 800.422.9329. The return of this form allows us to confirm that you have reviewed this notice and have taken appropriate action. Please contact Customer Service at 800.424.3278 if you have questions about the return and crediting process. The Customer Service organization can answer questions about tracking of the replacement instrument provided by the Edwards Sales Representative. If you have questions that have not been answered by this letter, please call Edwards Customer Service at 800.424.3278 from the hours of 6:00AM - 4:30PM PST .


  • Modelo / Serial
    Lot Number: 11211566.1, Exp. Date: 09/01/2017.
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Distributed to 3 customers in FL only.
  • Descripción del producto
    Edwards Lifesciences Ergonic Double Acting DeBakey Forceps with Narrow Straight Tip. Model Number ERGF01330. || The Edwards Surgical Instruments are designed to perform specialized functions in specific cardiac surgical or endoscopic procedures.
  • Manufacturer


  • Dirección del fabricante
    Edwards Lifesciences, LLC, 12050 Lone Peak Pkwy, Draper UT 84020-9414
  • Empresa matriz del fabricante (2017)
  • Source