Events

Retiro De Equipo (Recall) de Churchill Medical Systems 22Ga Winged Infusion Set

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
    61653
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1480-2012
  • Fecha de inicio del evento
    2012-04-16
  • Fecha de publicación del evento
    2012-05-01
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-03-28
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108644
  • 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
    Needle, hypodermic, single lumen - Product Code FMI
  • Causa
    Mislabeled: mbs-2210 code on case label -22ga winged infusion set, ; however, the product label states 20ga mbs-2010 code listed on device label.
  • Acción
    The firm, VYGON, sent an "URGENT MEDICAL DEVICE RECALL" letter dated April 16, 2012 to its customers via overnight, courier service. The letter described the product, problem and actions to be taken. The customers were instructed to check their stock for the products included within the scope of the recall; count and document their affected inventory; contact Vygon's Customer Service Department at 1-800-473-5414 for return merchandise authorization number; return the affected product; complete and immediately return the Acknowledgement and Inventory Return Form via fax to 215-672-6740 and send the original form with their shipment . Distributors were instructed to communicate this recall to their customers and provide them with the Acknowledgement and Inventory Return Form for completion and return. If you have any questions, please contact your local sales representative or Vygon's Customer Service Department at 1-800-473-5414, or by e-mail at customerservice@yygonus.com.

Device

Churchill Medical Systems 22Ga Winged Infusion Set
  • Modelo / Serial
    Lot Number: 1202077
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA (nationwide) including states of: IN, KS, KY, NY,MA, MI , and TX; and country of: Canada.
  • Descripción del producto
    Churchill Medical Systems Winged Infusion Set, 22Ga, 1", || Latex-Free Winged Infusion Set || Product Code: MBS-2210 || 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