Events

Retiro De Equipo (Recall) de Device Recall Bardex Lubricath

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., Urological Division.

¿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
    26828
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-1144-03
  • Fecha de inicio del evento
    2002-08-29
  • Fecha de publicación del evento
    2003-08-21
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2003-09-19
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=28523
  • 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, Urological (Antimicrobial) And Accessories - Product Code MJC
  • Causa
    On some units the inflation valve labeling is reversed on the prostate and bladder balloon inflation ports.
  • Acción
    Consignees were notified by letter on 8/29/2002. They were advised to pretest the catheter prior to inserting the catheter into the urethra.If the pretest indicates that the catheter balloons do not inflate as labeled, they were advised not to use the product and to contact Bard Medical Division Field Assurance Manager to have the product returned and credited.

Device

Device Recall Bardex Lubricath
  • Modelo / Serial
    Catalog Number 6016L22 (all units packaged from January 1999 and shipped prior to September 2002).
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    The product was distributed nationwide, Canada, Belgium and Germany.
  • Descripción del producto
    Bardex¿ Foley Catheter, 22 Fr 40cc- 20cc Ribbed Balloons, Coleman Model Red Latex, 3 Way Radiopaque, Lubricath Coated, Sterile, Single Use Device, C.R. Bard, Inc., Covington, GA 30014. The catheter is an open whistle tip with two eyes on the same side. It is made of red latex for added catheter stiffness and radiopacity, with a Lubricath hydrophilic coating. This product has 3 lumens; a lumen for drainage, a lumen for inflation of the bladder balloon, and a lumen for inflation of the prostatic balloon.
  • Manufacturer
    C.R. Bard, Inc., Urological Division

Manufacturer

C.R. Bard, Inc., Urological Division
  • Dirección del fabricante
    C.R. Bard, Inc., Urological Division, 8195 Industrial Blvd NE, Covington GA 30014
  • Source
    USFDA