Events

Retiro De Equipo (Recall) de Device Recall NovaGold

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 NEO METRICS, 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
    68279
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1747-2014
  • Fecha de inicio del evento
    2014-03-31
  • Fecha de publicación del evento
    2014-06-10
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-01-16
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127263
  • 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
    Endoscopic guidewire, gastroenterology-urology - Product Code OCY
  • Causa
    Neo metrics, inc. is recalling novagold guidewire because the tip may uncoil and / detach more frequently than anticipated. there have been no reports of illness or injury.
  • Acción
    NeoMetrics sent a letter dated March 31, 2014, to Boston Scientific. On March 24, 2014, Boston Scientific made NeoMetrics aware that Boston Scientific received 3 complaints from customers that the tip of the NovaGold guidewire detached and/or became uncoiled. Because the tips are breaking and/or uncoiling at a rate that was not anticipated, it has been decided that these units should be removed from the field. Therefore, NeoMetrics does not object to Boston Scientific executing this product removal in accordance with Section 4.4 of the distribution agreement. For further questions please call (763) 559-4440.

Device

Device Recall NovaGold
  • Modelo / Serial
    MO26343, MO26345, MO26724, MO27402, MO26342, MO26344, MO26731, MO27401, MO27660, MO27901, MO27659, MO27820, MO27899
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US and the countries of Austria, Belgium, Germany, Spain, France, Great Britain, Italy, Netherlands and Sweden.
  • Descripción del producto
    Boston Scientific, NovaGold High Performance Guidewire, Rx only, Sterilized using ethylene oxide, UPN M00552010 and M00552000, Manufactured by NeoMetrics Inc, 2605 Fernbrook Lane Suite J, Plymouth, MN 55447. || The NovaGold Guidewire is intended for use in selective cannulation of the biliary ducts including the common bile, pancreatic, cystic, right and left hepatic ducts, and to aid in the placement of diagnostic and therapeutic devices during endoscopic procedures.
  • Manufacturer
    NEO METRICS, INC.

Manufacturer

NEO METRICS, INC.
  • Dirección del fabricante
    NEO METRICS, INC., 2605 Fernbrook Ln N Ste J, Plymouth MN 55447-4756
  • Empresa matriz del fabricante (2017)
    Einhorn Verwaltungsges. Mbh
  • Source
    USFDA