Events

Retiro De Equipo (Recall) de Device Recall NaturaLyte Sodium Bicarbonate Liquid Concentrate

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 Fresenius Medical Care Holdings, 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
    58736
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-2551-2011
  • Fecha de inicio del evento
    2011-03-23
  • Fecha de publicación del evento
    2011-06-10
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-09-12
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100194
  • 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
    Dialysate concentrate for hemodialysis (liquid or powder) - Product Code KPO
  • Causa
    Mislabeled: incorrect lot number printed on case labels.
  • Acción
    Fresenius sent an CUSTOMER NOTIFICATION LETTER letter dated April 18, 2011, to all affected customers via Certified Mail, Return Receipt Requested. Fresenius also contacted affected customers by telephone April 18, 2011, The letter identified the product, the problem and the action needed to be taken by customer. Customers were instructed to examine their stock to determine whether they have the incorrect case label and are asked to remove the correctly labeled product from the incorrectly labeled case and discard the case. Acknowledgement forms were Fax-back forms for clinics and mail-back forms (including self-addressed, stamped envelopes), for home patients. Question or concerns should be directed to Fresenius Customer Service Team at 1- 800.323.5188.

Device

Device Recall NaturaLyte Sodium Bicarbonate Liquid Concentrate
  • Modelo / Serial
    Lot Number: 11 BMLB005 (Incorrect Lot Number: 11 BLMB005)
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution--AL, CA, CT, FL, GA, NJ, NV, NY, OR, PA, and WA
  • Descripción del producto
    Naturalyte@ Sodium Bicarbonate Liquid Concentrate, Dialysate Concentrate for Hemodialysis Liquid || Part number: 08-4000-LB || Formulated to be used with a three stream hemodialysis machine which is calibrated for acid and bicarbonate concentrates
  • Manufacturer
    Fresenius Medical Care Holdings, Inc.

Manufacturer

Fresenius Medical Care Holdings, Inc.
  • Dirección del fabricante
    Fresenius Medical Care Holdings, Inc., 920 Winter St, Waltham MA 02451-1521
  • Empresa matriz del fabricante (2017)
    Fresenius SE & Co KGaA
  • Source
    USFDA