Events

Retiro De Equipo (Recall) de Device Recall Vygon

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
    70369
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1478-2015
  • Fecha de inicio del evento
    2015-01-15
  • Fecha de publicación del evento
    2015-04-21
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-02-25
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=133361
  • 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
    Potential for leaking caused by insufficient bond between needleless device and female luer.
  • Acción
    Vygon sent an Urgent Medical Device Recall letter dated January 15, 2015, to all affected customers via email or courier service. The letter instructs consignees to check stock for products included in the scope of the recall, count and document the affected inventory on the "Recall Acknowledgement and Inventory Return Form" and fax or email the form to Vygon. Vygon customer service will then contact the customer to issue a Return Merchandise Authorization Number so the inventory can be replaced at no cost. Distributors were provided with instructions on how to handle product that was further distributed by them. If after 30-days, product is not returned from each consignee, Vygon will follow-up with the consignee to obtain a status of the product return. Customers with questions were instructed to contact Vygon Customer Service at 1-800-473-5414, or by e-mail at customerservice@vygonus.com.

Device

Device Recall Vygon
  • Modelo / Serial
    1310051 1312063
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution including TX, OH, NY, CA, UT, PA, MA, NY, VA, and IL.
  • Descripción del producto
    6" Trifurcated set with Bionectors, Product Code: BN-944 || Accessory device used to administer medical fluids
  • 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