Events

Retiro De Equipo (Recall) de Device Recall BioFlo PICC with ENDEXO and PASV Valve Technology, IR145 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., an AngioDyamics Company.

¿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
    73598
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1982-2016
  • Fecha de inicio del evento
    2016-03-14
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2018-06-11
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=146665
  • 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
    Catheter,intravascular,therapeutic,long-term greater than 30 days - Product Code LJS
  • Causa
    Picc catheters that contain valve(s) manufactured prior to july 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling through the picc catheter.
  • Acción
    Navilyst Medical distributed Urgent Voluntary Medical Device Recall notification letters on March 14, 2016, and Reply Tracking forms to their customers via courier service. Customers were asked to immediately remove any affected (recalled) product from their 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 the recall notice to all sites to which you have distributed affected product. If affected product is located in your institution, please call Navilyst Medical Customer Service at 1-800-772-6446 Monday to Friday, 8 am - 7 pm, EST to obtain a replacement or credit for your returned product. Promptly complete, sign and return the enclosed Reply Verification Tracking Form (even if you do not have any product to return) by fax to 1-800-782-1357. For questions regarding this recall call 518-792-4112.

Device

Device Recall BioFlo PICC with ENDEXO and PASV Valve Technology, IR145 Kit
  • Modelo / Serial
    Batch/Lots: 4732400, 4753201, 4776149, 4783743, 4797578, 4819459, 4830558 & 4836573. Use By Date Range 2016-05-31 to 2016-12-31.
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution US (Nationwide) Internationally to AU, GR, SE, SA, IN, CA, GB, BR, BE, NL, ES, KR, HK, AE, IT and ES.
  • Descripción del producto
    BioFlo PICC with ENDEXO and PASV Valve Technology, IR-145 Kit, 6F-55cm, UPN H965458430 & UPN H965458840, Rx ONLY || The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media. Non-valve lumens are indicated for central venous pressure monitoring
  • Manufacturer
    Navilyst Medical, Inc., an AngioDyamics Company

Manufacturer

Navilyst Medical, Inc., an AngioDyamics Company
  • Dirección del fabricante
    Navilyst Medical, Inc., an AngioDyamics Company, 10 Glens Falls Tech Park, Glens Falls NY 12801-3864
  • Empresa matriz del fabricante (2017)
    AngioDynamics Inc
  • Source
    USFDA