Events

Retiro De Equipo (Recall) de Device Recall EASYMax N SelfMonitoring Blood Glucose System

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 Oak Tree International Holdings, LLC, 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
    52352
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1937-2009
  • Fecha de inicio del evento
    2009-05-26
  • Fecha de publicación del evento
    2009-09-10
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-09-27
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=82772
  • 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, test, blood glucose, over the counter - Product Code NBW
  • Causa
    Blood glucose meters, which were set to the mmol/l. unit of measure, rather than the accepted/labeled mg./dl unit of measure, were distributed.
  • Acción
    EPS Technology issued a certified notification letter to the sole distributor/customer: GEMCO, Coconut Creek, FL dated May 26, 2009. The letter describes the potential preset error and its possible consequences to the user/customer. The letter goes on to inform the distributor that EPS Technology Corp. will be sending out letters to all affected user/customers during a direct mailing. If the error is found, the user/customer can either: 1) have the firm's Customer Service Dept. instruct them as to how to fix the unit, or 2) request that a replacement meter be sent to them. For further information, contact EPS Technology Customer Service at 1-866-994-3345.

Device

Device Recall EASYMax N SelfMonitoring Blood Glucose System
  • Modelo / Serial
    Lot Number: 222090401, Serial Numbers: 27U000001 - 27U001700, Strip Expiration Date: 2010/09;   Lot Number: 222090902: Serial Numbers: 27U001702 - 27U003401, Strip Expiration Date: 2010/11;   Lot Number: 222091101, Serial Numbers: 27U003404 - 27U005903, Strip Expiration Date: 2010/11;   Lot Number: 222091103, Serial Numbers: 27U008404 - 27U008503, Strip Expiration Date: 2010/11;   Lot Number: 222091102, Serial Numbers: 27U005904 - 27U008242, Strip Expiration Date: 2010/11;   Lot Number: 222091103, Serial Numbers: 27U008243 - 27U008430, Strip Expiration Date: 2010/11; and   Lot Number: 222091201, Serial Numbers: 27U008504 - 27U010503, Strip Expiration Date: 2010/1.
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution -- AL, AR, AZ, CA, CT, FL, GA, IL, IN, KS, KY, LA, MD, ME, MI, MS, NC, NE, NH, NJ, NY, OH, OR, PA, SC, TN, TX, UT, VA, VA, WA, WY and HI.
  • Descripción del producto
    EASYMax N. Self-Monitoring Blood Glucose System, distributed in cardboard carton kits. Each kit contains the following components: Blood Glucose Meter; Test Strip x 10 ct.; Normal Control Solution; Carrying Case; Alkaline Battery x 2 ct.; Lancets x 5 ct.; Lancing Device; AST Lancing Device Cap; User's Manual; Test Strip Instructions and Control Solution Instructions. || Indicated for use at home by persons with diabetes or in clinical setting by healthcare professionals as an aid to monitor the effectiveness of diabetes control.
  • Manufacturer
    Oak Tree International Holdings, LLC, Inc.

Manufacturer

Oak Tree International Holdings, LLC, Inc.
  • Dirección del fabricante
    Oak Tree International Holdings, LLC, Inc., 1209 Lowell St Ste 10, Elyria OH 44035-4803
  • Source
    USFDA