Events

Retiro De Equipo (Recall) de Device Recall Genicon

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 Genico, Inc., dba Genicon.

¿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
    50739
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1956-2009
  • Fecha de inicio del evento
    2008-05-08
  • Fecha de publicación del evento
    2009-07-02
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2009-10-01
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=76839
  • 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
    Apparatus, suction, single patient use, portable, nonpowered - Product Code GCY
  • Causa
    Genicon is recalling the genicon disposable suction irrigation 5mm 700-005-010 and 10mm 700-005-005 tube sets. the caps on the trumpet valves of the devices could fall off, resulting in the malfunction of the suction irrigation device.
  • Acción
    All four consignees were contacted by email and fax on May 8, 2008. Wholesalers were requested to forward copies of Genicon's recall letter dated May 8, 2009 and response form to their customers. Instructions for product return was provided. Direct questions about the recall to Genicon by calling 407-657-4851 (in United States) or 0118 930 5333 (in United Kingdom).

Device

Device Recall Genicon
  • Modelo / Serial
    Lot Numbers: 441071225, 434071227, 434080237 and 434080373.
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- US (MO and IA), United Kingdom, Netherlands and United Arab Republic.
  • Descripción del producto
    Genicon, RX Only, Sterile EO. Genicon 6869 Stapoint Court, Suite 114 Winter Park, FL U.S.A. 32792. EC REP Genicon Europe, Ltd. 44 Airedale Avenue, Chiswick London U.K. W4 2NW. Catalog Number 700-005-010, 5MM. || A suction irrigation device. This device is used in conjunction with an insufflator during laparoscopic surgery to provide suction and irrigation to the surgical site. The suction irrigation product contains a trumpet valve handpiece that fits into either the left or right hand. The double sealing valve system provides operation of the suction and irrigation functions while preventing fluid leakage.
  • Manufacturer
    Genico, Inc., dba Genicon

Manufacturer

Genico, Inc., dba Genicon
  • Dirección del fabricante
    Genico, Inc., dba Genicon, 6869 Stapoint Ct Ste 114, Winter Park FL 32792-6603
  • Empresa matriz del fabricante (2017)
    Genicon Inc
  • Source
    USFDA