Events

Retiro De Equipo (Recall) de Device Recall NAMIC 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 AngioDynamics 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
    72957
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1345-2016
  • Fecha de inicio del evento
    2015-11-03
  • Fecha de publicación del evento
    2016-04-07
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-03-16
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142589
  • 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
    Procedure products initiated the recall due to the inner lumen of the needles not meeting the intended specification. specifically, at least a portion of the affected lot is unable to accept a 0.038" guidewire as intended. in some cases the inner lumen was found to be 0.036".
  • Acción
    On November 03, 2015, Navilyst Medical distributed Urgent Voluntary Medical Device Recall notices to their customers via courier service. Customers were advised to immediately remove the recall product from inventory and to segregate the products in a secure location for return to AngioDynamics, Inc. Customers should immediately forward a copy of the recall notification letter to all sites if these products were further distributed. If affected product is located in your institution, please call AngioDynamics, Inc. Customer Service at 1-800-772-6446 between 8:00 a.m. and 7:00 p.m. (Monday - Friday 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). The Reply Verification Tracking form can be submitted via fax to: Attn: Convenience Kits - Procedure Products Needles 1-800-782-1357 or via email to rdenino@angiodynamics.com or sbaxter@angiodynamics.com.

Device

Device Recall NAMIC Convenience Kit
  • Modelo / Serial
    Batch/Lo. 4925662 Use By 2017-02
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Nationwide in the states of CA, IL, MA, SC, TX
  • Descripción del producto
    NAMIC CONVENIENCE KIT HOLYOKE HOSPITAL SPECIAL PROCEDURE KIT, REF Catalog No. 60080094, UPN Product No. H749600800941 || Product Usage - This needle is intended to be placed over the guidewire to enlarge the opening in the vessel, and is then removed before sliding the catheter over the guidewire
  • Manufacturer
    AngioDynamics Inc.

Manufacturer

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