Events

Retiro De Equipo (Recall) de Minor Surgery Bipolar Cable

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 Ellman International, Inc..

¿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
    75351
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0748-2017
  • Fecha de inicio del evento
    2016-09-07
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=150114
  • 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
    Mislabeling of the "expiration date". the expiration date on the outer box and the individual pouches do not match. the expiration date on the box is correct with a date of 2018-02.
  • Acción
    Cynosure, Inc. dba Ellman distributed Urgent Medical Device Recall Notices dated September 6, 2016, and response forms to their customers via UPS overnight. Cynosure has identified an error in the Expiration Date on the label of the Minor Surgery Bipolar Cable pouch. The Expiration Date on the individual pouches that are provided in the 5 pack boxes do not match the Expiration Date on the box. The Expiration Date on the box is correct with a date of 2018-02, but the label on the individual pouches has a date of 2021-02. Actions To Be Taken - Return any cables subject to recall. You will be contacted by a Cynosure Customer Service Representative who will provide you with a RMA number for any cables that are being returned. Complete and return the response form via email to choy@cynosure.com. Cynosure will replace affected products at no charge upon receipt of the returned cables. Customers with questions should call 978-256-4200 or 800-886-2966. For questions regarding this recall call 516-267-6502.

Device

Minor Surgery Bipolar Cable
  • Modelo / Serial
    Lot Numbers 45572 (Box), (Individual packages) 48543, 50382, 48543, 50704, 50858 Exp Date - 2018-02
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US including CA, FL, MA, MD, MI, MN, MS, OH, PA, VA, TX & WV; **International**Australia, Bangladesh, Greece, Italy, Japan, Lebanon, Russian Federation, Singapore, Spain & Vietman.
  • Descripción del producto
    ellman A CYNOSURE COMPANY Minor Surgery Bipolar Cable, Contents: Five (5) Disposable Bipolar Cables,STERILE || The Minor Surgery Bipolar Cable is an accessory that is used to connect the bipolar handpieces to the RF generator for electrosurgical procedures that require the bipolar waveform.
  • Manufacturer
    Ellman International, Inc.

Manufacturer

Ellman International, Inc.
  • Dirección del fabricante
    Ellman International, Inc., 400 Karin Ln, Hicksville NY 11801-5352
  • Source
    USFDA