Events

Retiro De Equipo (Recall) de XForce Nephrostomy Balloon Dilation Catheter Kit with Inflation Device

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
    75452
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0363-2017
  • Fecha de inicio del evento
    2016-10-12
  • Estado del evento
    Completed
  • 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=150405
  • 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
    Catheter, nephrostomy - Product Code LJE
  • Causa
    Contract manufacturer packaged an incorrect sheath with the product. packaged 30fr instead of 24fr.
  • Acción
    The firm, Bard Medical, sent an "URGENT: MEDICAL DEVICE PRODUCT RECALL" letter dated 10/13/2016 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately examine their inventory and quarantine product subject to recall; do not use or further distribute any affected product; complete and return the attached Recall & Effectiveness Check Form regardless of whether or not you have any of the affect product by fax to 1-770-784-6469 or email a scanned copy to BMD.FieldAction@crbard.com by October 24, 2016, and if you have further distributed any units of the affected lot, identify your customers and notify them at once of the product recall. If you have any questions, contact BMD Recall Coordinator at 1-800-793-8110.

Device

XForce Nephrostomy Balloon Dilation Catheter Kit with Inflation Device
  • Modelo / Serial
    Lot BMZCE039, Expiration Date 2018-12-31
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: US distribution to: CA, KS, MO, NY, VA, WA, and to countries of: China, Italy, Sweden and United Kingdom.
  • Descripción del producto
    X-Force Nephrostomy Balloon Dilation Catheter Kit with Inflation Device, PTFE Sheath, 8 mm x 15 cm, Product Code 996081 || The product is a dual lumen catheter with a 24 (8mm) or 30Fr (10mm) balloon mounted on the distal tip. It has a radiopaque tip and radiopaque marker beneath the balloon. It is recommended for use in the dilation of the nephrostomy tact and for placement of the working sheath.
  • 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