Events

Retiro De Equipo (Recall) de Device Recall NAMIC (TM) Convenience Kit

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 Navilyst Medical, 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
    70322
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1159-2015
  • Fecha de inicio del evento
    2015-01-09
  • Fecha de publicación del evento
    2015-02-26
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-03-10
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=133393
  • 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
    Cardiovascular procedure kit - Product Code OEZ
  • Causa
    The labelled expiration dating of the affected product is not fully supported by shelf life verification testing, which may result in a sterility breach. use of a fluid management convenience kit, where sterility has been breached, may result in an increased risk of infection.
  • Acción
    Navilyst Medical sent an Urgent Medical Device Recall Notification letter dated January 9, 2015 to US customers (end users) via Federal Express. On January 20, 2015, Recall Notification Packages were sent via Federal Express to 2 International consignees (distributors). the letter identified the affected product, problem and actions to be taken. Customers are instructed to: " Immediately remove the recall product from your inventory (whether in labs, Central Supply, Shipping and Receiving or ANY other location). " Segregate this product in a secure location for return to Navilyst Medical. " Immediately forward a copy of this recall notification to all sites to which you have distributed affected product. " Complete and return the Reply Verification Tracking Form.

Device

Device Recall NAMIC (TM) Convenience Kit
  • Modelo / Serial
    Lots 4239391, 4243486, 4248969, 4253169, 4260193, 4268148, 4279179, 4288388, 4298216, 4306873, 4315493, 4322272, 4330719, 4338372, 4342371, 4346174, 4355672, 4362474, 4372470, 4384182, 4393676, 4398975, 4403978,  4413500, 4423296, 4427571, 4438026, 4439842, 4441465, 4442714, 4448567, 4456976, 4466287, 4469567, 4476873, 4485284, 4492411, 4499668, 4501959, 4515770, 4547972, 4556175, 4561968, 4566668.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Nationwide and the countries of: Canada, and Guam.
  • Descripción del producto
    NAMIC Convenience Kit, UPN H7496005216131, REF/Catalog No. 600521613, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588. || Product Usage: || NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.
  • Manufacturer
    Navilyst Medical, Inc

Manufacturer

Navilyst Medical, Inc
  • Dirección del fabricante
    Navilyst Medical, Inc, 10 Glens Falls Technical Park, Glens Falls NY 12801
  • Empresa matriz del fabricante (2017)
    Navilyst Medical, Inc
  • Source
    USFDA