Events

Retiro De Equipo (Recall) de Bard Dimension Stone Basket

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 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
    69462
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0163-2015
  • Fecha de inicio del evento
    2014-10-07
  • Fecha de publicación del evento
    2014-10-31
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-06-12
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=130716
  • 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
    Dislodger, stone, basket, ureteral, metal - Product Code FFL
  • Causa
    The product is non-sterile.
  • Acción
    Bard sent an Urgent: Medical Device Recall letter to each customer on 10/7/2014 with proof of delivery notice. Wholesalers were asked to conduct a sub-recall. Letter identify the affected product, problem and actions to be taken. Customers were instructed to examine their inventory and quarantine product subject to recall, do not use or further distribute any of the affected product, remove and return affected product to Bard Medical Division, and if the product have been further distributed identify your customers and notify them at once of the product recall. Customers were instructed to complete the enclosed Recall & Effectiveness Check Form and fax to 1-770-784-6469. For questions call 1-770-784-6471.

Device

Bard Dimension Stone Basket
  • Modelo / Serial
    Product code: 042316, Lot number: BMXJM031
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution in the states of AL, FL, NJ, NY, NC, PA, SC, TX, WI, and countries of Germany, Italy, Kuwait, and Luxembourg.
  • Descripción del producto
    Bard Dimension Stone Basket || Product Usage: The Bard Dimension Stone basket is a teardrop-shaped basket with the ability to capture stones by, opening and closing the basket and articulating or moving the basket from side to side. The device consists of 3 main parts; handle, shaft and basket. It is intended to use in the endoscopic removal of renal and ureteral stones.
  • Manufacturer
    C.R. Bard, Inc.

Manufacturer

C.R. Bard, Inc.
  • Dirección del fabricante
    C.R. Bard, Inc., 8195 Industrial Blvd Ne, Covington GA 30014-1497
  • Empresa matriz del fabricante (2017)
    Becton, Dickinson and Company
  • Source
    USFDA