Events

Retiro De Equipo (Recall) de Device Recall Lifeguard Infusion Set with Smartsite, 20Ga, 1

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 Churchill Medical Systems, 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
    64464
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0914-2013
  • Fecha de inicio del evento
    2013-01-21
  • Fecha de publicación del evento
    2013-03-06
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-09-10
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116188
  • 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
    Set, administration, intravascular - Product Code FPA
  • Causa
    The label on the device states that the item number is clgy-2210 when the item number on the device label should read clgy-2010. this is a 20ga huber needle set; however, the product label states the pouch contains a 22ga set.
  • Acción
    Vycon sent an Urgent Medical Device Recall letter dated January 21, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed check their stock for the affected product and immediately cease use and distribution and quarantine all affected product immediately. Count and document their affected inventory on the Recall Acknowledgement and Inventory Return Form. Customers were instructed to fax or email the form to Vygon including customer contact information. All affected product would be credited or replaced at no cost to the customer. Customers with questions were instructed to call 1-800-473-5414, or by e-mail at customerservice@vygonus.com. For questions regarding this recall call 603-743-5988.

Device

Device Recall Lifeguard Infusion Set with Smartsite, 20Ga, 1
  • Modelo / Serial
    Lot #1210099
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution including MO, IL, FL, PA, VA, MO, NY, NE, NH, and OH.
  • Descripción del producto
    Lifeguard Infusion Set with Smartsite, 20Ga, 1, CLGY-2010 || Huber type needle set used for the infusion of medical fluids into implantable ports.
  • Manufacturer
    Churchill Medical Systems, Inc.

Manufacturer

Churchill Medical Systems, Inc.
  • Dirección del fabricante
    Churchill Medical Systems, Inc., 87 Venture Drive, Dover NH 03820-5914
  • Empresa matriz del fabricante (2017)
    Soc Part Financiere Pierre Simonet
  • Source
    USFDA