Events

Retiro De Equipo (Recall) de Device Recall NIOA / NIOP is an instant IO access device

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 Waismed Ltd.

¿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
    75008
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2680-2016
  • Fecha de inicio del evento
    2016-08-18
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-12-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149107
  • 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
    Needle, hypodermic, single lumen - Product Code FMI
  • Causa
    Waismed received a report in which during the operation of the nio-a, the needle was not released from the device as expected. the device was placed on the floor and after several minutes the needle was released spontaneously. nio-a and the nio-p models have the same activation mechanism. however, none of the affected lots of the nio-a are distributed in the us, and thus the company is only recalling a single lot of nio-p in the us.
  • Acción
    The firm emailed the US Consignees on August 18, 2016 that they were conducting a recall on the NIO/A and NIO/P products. The US distributor shall contact the customers and will collect the products from each of the customers. The recalled products shall be moved to Storage quarantine within one week. The company shall keep track on the process and the recall efficacy.

Device

Device Recall NIOA / NIOP is an instant IO access device
  • Modelo / Serial
    1620005
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    WI, TX, CA, LA and the following countries: UK, Spain, Poland, Israel, Czech Republic, France, Belgium, Denmark, Italy, Cyprus, Austria, Greece, Slovenia, Australia, Germany, Estonia, New Zealand, Switzerland, Costa Rica, Guatemala, Canada, Malaysia, Poland, Singapore, Lithuania, Romania
  • Descripción del producto
    NIO-A / NIO-P is an instant IO access device comprises housing with spring load mechanism that injects a trocar needle into the bone marrow of a patient and allows connection of syringe or IV administration set. || The NIO-A is intended for adults above 12 years old and the NIO-P is intended for pediatric patients 3 - 12 years of age.
  • Manufacturer
    Waismed Ltd

Manufacturer

Waismed Ltd
  • Dirección del fabricante
    Waismed Ltd, 10, Amal St, Rosh Haayin Israel
  • Empresa matriz del fabricante (2017)
    Waismed Ltd
  • Source
    USFDA