Events

Retiro De Equipo (Recall) de Composix LP with Echo

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 Davol, Inc., Subs. C. R. Bard, 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
    68124
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1690-2014
  • Fecha de inicio del evento
    2014-04-24
  • Fecha de publicación del evento
    2014-06-02
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-12-23
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127047
  • 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
    Laparoscope, general & plastic surgery - Product Code GCJ
  • Causa
    Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal.
  • Acción
    Davol, Inc., Subs. C. R. Bard, Inc.sent an Urgent Medical Device Recall letter dated April 28, 2014, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to examine their inventory and quarantine product subject to the recall, contact Davol Customer Service at 1-800-556-6275 or C.R. Bard's Medical Services and Support Department at 1-800-562-0027 for instructions on how to return the product to Davol, Consignees were also instructed to complete and return the recall effectiveness check form, and notify their customers if the product was further distributed. For questions regarding this recall call 1-800-556-6275.

Device

Composix LP with Echo
  • Modelo / Serial
    Lot Number: HUXH0695
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) and Internationally to AUSTRIA, BELGIUM, CANADA, CYPRUS, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, IRELAND, ITALY, LUXEMBOURG, NETHERLANDS, NORWAY, POLAND, PORTUGAL, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, and UNITED KINGDOM
  • Descripción del producto
    Bard¿ Ventralight" ST Mesh with Echo PS" 4"x6" Reorder Number: 5955460 || Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
  • Manufacturer
    Davol, Inc., Subs. C. R. Bard, Inc.

Manufacturer

Davol, Inc., Subs. C. R. Bard, Inc.
  • Dirección del fabricante
    Davol, Inc., Subs. C. R. Bard, Inc., 100 Crossings Blvd, Warwick RI 02886-2850
  • Empresa matriz del fabricante (2017)
    Becton, Dickinson and Company
  • Source
    USFDA