Events

Retiro De Equipo (Recall) de NaturaLyte Liquid Acid

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 Renal Therapies Group, LLC.

¿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
    79236
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1010-2018
  • Estado del evento
    Open, Classified
  • 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=161727
  • 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
    The label specifies the potassium concentration is 2.0 meq/l. some of the product in the affected lot was found to have a potassium concentration of 2.25 meq/l.
  • Acción
    The firm, Fresenius Medical Care, sent an "URGENT - MEDICAL DEVICE RECALL" letter dated 10/4/2017 to its Consignees. The letter described the product, problem and actions to be taken. The Consignees are instructed to: " Immediately examine your stock to determine whether you have any Naturalyte¿ Liquid Acid Concentrate from the lot listed. " If any product of this lot is found, discontinue use immediately. " Place all units in a secure, segregated area. " Contact your FMCRTG, LLC Customer Service Team at 1-800-323-5188 for instructions on how to return the recalled product. " Promptly fill out and return the attached Reply Form via fax to: 781-699-9796 ATTN: Quality Department or SCAN and email to: NOTIFYRA@fmc-na.com.' and "Route the letter to others in your organization that may have any of the affected product that is subject to this recall. Please note that the Naturalyte¿ Liquid Acid Concentrate matching the Lot Number listed in the notification is the only lot subject to this recall. If you have any additional medical concerns or questions, please contact Medical Information and Communication: 855-616-2309 or Website: www.fresenius-medinfo.com.

Device

NaturaLyte Liquid Acid
  • Modelo / Serial
    Lot # 17KTAC076; UDI-00840861101696
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Distribution to states of: CA, FL, KS, LA, and TX.
  • Descripción del producto
    NaturaLyte¿ Liquid Acid Concentrate 2.0 mEq/L, Model # 08-2251-0 || 3.43 liter bottle || This concentrate is formulated to be used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
  • Manufacturer
    Fresenius Medical Care Renal Therapies Group, LLC

Manufacturer

Fresenius Medical Care Renal Therapies Group, LLC
  • Dirección del fabricante
    Fresenius Medical Care Renal Therapies Group, LLC, 920 Winter St, Waltham MA 02451-1521
  • Empresa matriz del fabricante (2017)
    Fresenius SE & Co KGaA
  • Source
    USFDA