Events

Retiro De Equipo (Recall) de Device Recall ACCUCHEK FlexLink Plus

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 Roche Insulin Delivery Systems 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
    58015
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-1482-2011
  • Fecha de inicio del evento
    2011-02-24
  • Fecha de publicación del evento
    2011-03-10
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-07-27
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97977
  • 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
    Infusion Pump - Product Code FRN
  • Causa
    There is the potential to kink or bend the cannula when inserting the accu-chek flexlink plus infusion set. this can lead to under delivery and elevation of blood glucose levels.
  • Acción
    Roche Insulin Delivery Systems sent urgent Product Recall letters, dated 2/21/2011. The letter identified the affected product and described the issue regarding kinked or bent cannulas. The firm requests that customers discontinue use of the ACCU-CHEK FlexLink Plus infusion set and return the unused stock. Customers are to contact their health care provider to determine if changes to their pump therapy are needed and how to temporarily continue insulin pump therapy without the ACCU-CHEK FlexLink Plus infusion set. The attached Customer Reply Card should be completed and return via mail or fax per the instructions on the card. The letter also lists some additional information pertaining to signs and symptoms. Questions regarding this recall should be directed to ACCU-CHEK Customer Care at 1-800-688-4578, 24 hours a day, 7 days a week.

Device

Device Recall ACCUCHEK FlexLink Plus
  • Modelo / Serial
    Part Number: 05511038001.  Lots: GWX 001 up to GWX 206 and GWY 001 up to GWY 033.
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- US and Canada.
  • Descripción del producto
    ACCU-CHEK FlexLink Plus, subcutaneous infusion set. Part Number 05511038001. AC FLEXLINK PLUS 10MM CANNULA. || An infusion set for the subcutaneous infusion of insulin administered with micro dosage insulin pumps. || Made in Germany || Manufactured for and Distributed by || Roche Insulin Delivery Systems Inc. || Fishers, IN 46037, USA || Toll Free: 1-800-280-7801 || Roche Diabetes Care AG || 3401 Burgdorf, Switzerland
  • Manufacturer
    Roche Insulin Delivery Systems Inc.

Manufacturer

Roche Insulin Delivery Systems Inc.
  • Dirección del fabricante
    Roche Insulin Delivery Systems Inc., 11800 Exit 5 Pkwy Ste 120, Fishers IN 46037-7989
  • Empresa matriz del fabricante (2017)
    Roche Holding AG
  • Source
    USFDA