Events

Retiro De Equipo (Recall) de BARD Mesh Preshaped

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., Sub. 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
    57008
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0446-2011
  • Fecha de inicio del evento
    2010-10-15
  • Fecha de publicación del evento
    2010-11-23
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-10-27
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95166
  • 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
    mesh, surgical, polymeric - Product Code FTL
  • Causa
    Mislabeled: the labeled bard¿ mesh pre-shaped product code 0112700 (1.8" x 4.0"/4.5cm x 10cm), but the contents are the bard¿ mesh large pre-shaped product code 0113700 (2.4" x 5.4"/6.0cm x 13.7cm).
  • Acción
    Davol issued an "URGENT MEDICAL DEVICE RECALL" letter on October 15, 2010, via Overnight Delivery to all customers. The letter describes the product, the problem and the action to be taken by the customers. The customers were instructed to immediately examine their inventory and quaratine the product; identify and notify customers they may have further distributed the product to of this recall; contact Davol Customer Service at 1-800-556-6275 for instructions on how to return product, and complete and return the attached EFFECTIVENESS CHECK form via fax to 1-401-825-8753. If you have an questions, please contact Davol Customer Service Department at 1-800-556-6275 or C. R. Bard's Medical Service Support Department at 1-800-562-0027.

Device

BARD Mesh Preshaped
  • Modelo / Serial
    Lot : HUUF0412.
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide distribution
  • Descripción del producto
    BARD¿ Mesh Pre-shaped (1.8" x 4.0"/4.5cm x 10cm) || Product code: 0112700 || Intended use: Bard Pre-shaped mesh is a pre-shaped mesh constructed of knitted polypropylene monofilaments. It is indicated for the repair of inguinal hernia defects
  • Manufacturer
    Davol, Inc., Sub. C. R. Bard, Inc.

Manufacturer

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