Events

Retiro De Equipo (Recall) de Device Recall Diacap(R) Ultra Dialysis Fluid Filter

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 B. Braun Medical, 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
    64504
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1183-2013
  • Fecha de inicio del evento
    2013-03-01
  • Fecha de publicación del evento
    2013-04-26
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-09-03
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116364
  • 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
    System, dialysate delivery, central multiple patient - Product Code FKQ
  • Causa
    There is the potential of the residual moisture of the diacap ultra membrane being reduced over time, which results in the reduction of the membrane permeability (ultrafiltration coefficient).
  • Acción
    B. Braun Medical Inc. sent and "URGENT RECALL NOTICE" dated February 28, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact the Customer Support Department at (800) 848-2066 for questions regarding this issue. This recall was expanded on/about June 18, 2013 to include additional lot #s 305010113 and 305000113. Customers were notified via certified mail on/about June 14, 2013.

Device

Device Recall Diacap(R) Ultra Dialysis Fluid Filter
  • Modelo / Serial
    Lot numbers 302950410, 309910111, 313050411, 314300511, 316040711, 316450711, 305880812, 306301012, and 306311012.  This recall was expanded on/about June 18, 2013 to include additional lot #s 305010113 and 305000113.
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distribution and manufacturing dates for the expansion lots was reported as 5/23-6/14/2013 and 1/22-24/2013 respectively. Nationwide Distribution including the states of AZ, CA, DE, FL, GA, HI, IA, ID, IL, KS, KY, LA, MN, MO, NJ, NM, NY, OH, OR, PA, SC, SD, TN, TX, UT, WA and WV.
  • Descripción del producto
    Diacap(R) Ultra Dialysis Fluid Filter, Catalog Number 7107367. || Intended to filter bacteria and endotoxins from dialysis fluid.
  • Manufacturer
    B. Braun Medical, Inc.

Manufacturer

B. Braun Medical, Inc.
  • Dirección del fabricante
    B. Braun Medical, Inc., 901 Marcon Boulevard, Allentown PA 18109-9512
  • Empresa matriz del fabricante (2017)
    Ludwig G. Braun Gmbh U. Co. Kg
  • Source
    USFDA