Events

Retiro De Equipo (Recall) de VCATH Insertion Kits

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 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
    58514
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2223-2011
  • Fecha de inicio del evento
    2011-04-05
  • Fecha de publicación del evento
    2011-05-19
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-11-22
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99502
  • 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
    I.V. Start Kit - Product Code LRS
  • Causa
    Firm received recall notice from their contract manufacturer due to visible particulates in bacteriostatic sodium chloride injection, usp 0.9%, 30 ml vials that are included in insertion kits.
  • Acción
    Neo Medical forwarded Urgent Recall Notices to Dealers and customers on April 5, 2011 via fax. Neo Medical Customer Care also contacted customers by phone on April 7, 2011, followed by Urgent Product Recall Notification letters were sent on April 11, 2011 along with a copy of the Recall Notification from Centurion. The letter requested that customers with affected lots immediately discontinue distribution and contact the end users instructing them to stop dispensing the product. Customers were to complete the accountability information even if inventory had been depleted and fax it to 510-353-9025. In order to return the affected product, customers should contact the Complaint Coordinator at 925-719-2197 or pjduvall@neomedicalinc.com. Replacement or credit would be issued for all product returned.

Device

VCATH Insertion Kits
  • Modelo / Serial
    Lot # Expiration Date 2009092850 5/31/2011 2010012950 5/31/2011 2010030150 8/31/2011 2010043050 8/31 2011 2010061850 12/31/2011 2010062950 12/31/2011 2010082650 12/31/2011
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- USA, including states of MO, WA, PA, CA, OH, UT, TX and Canada.
  • Descripción del producto
    V-CATH Insertion Kits, Sterile; Product Code Number: 301-00; || Manufactured by Centurion Medical Products for Neo Medical; || 42514 Albrae Street, Fremont, CA 94538
  • Manufacturer
    Neo Medical, Inc.

Manufacturer

Neo Medical, Inc.
  • Dirección del fabricante
    Neo Medical, Inc., 42514 Albrae St., Fremont CA 94538
  • Empresa matriz del fabricante (2017)
    Neo Medical Inc
  • Source
    USFDA