Events

Retiro De Equipo (Recall) de Device Recall Churchill Medical

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
    59466
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-3049-2011
  • Fecha de inicio del evento
    2011-07-15
  • Fecha de publicación del evento
    2011-08-22
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-03-27
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102841
  • 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
    kit, i.v. start - Product Code LRS
  • Causa
    Outer kit labeled expiration date longer than the expiration of the shortest expired product.
  • Acción
    Churchhill Medical Systems, Inc A Vygon Company issued an URGENT MEDICAL DEVICE RECALL letter was via overnight courier mail on July 15, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The product was requested to be returned. Distributors were provided with instructions to communicate the recall to customers who received the affected product by providing a copy of the notification and a copy of the Recall Acknowledgement and Inventory Return Form. The form should be completed in its entirety, signed and returned to the Distributor. Contact your local sales representative or Vygon's Customer Service Department at 1-800-473-5414, or by email to customerservice @vygonus.com

Device

Device Recall Churchill Medical
  • Modelo / Serial
    Lot Numbers: 609134, 610166, 611100, 612074, 701180, 703021, 704088 706150, 707106, 708503, 709052, 710051, 711074, 711176 801504, 802064, 803116, 805120, 810040, 810150, 812020 902044, 903117, 906039, 907156, 908040, 910558, 912038 1007141
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution
  • Descripción del producto
    Churchill Medical Latex-Free IV Start Kit || Product Code: AMS-623ATLF || The kit includes a tourniquet, alcohol prep pads, a PVP ampule swab, 1 3M" Transpore tape roll, 2 gauze sponges, a 3M" Tegaderm" dressing, and a dressing change label || AMS-623ATLF is a convenient kit that aids in preparing the insertion site for the start of intravenous therapy
  • 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