Events

Retiro De Equipo (Recall) de Device Recall Silicone CTS Tracheostomy Tube

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 Arcadia Medical Corporation.

¿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
    58828
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2657-2011
  • Fecha de inicio del evento
    2011-05-08
  • Fecha de publicación del evento
    2011-06-24
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-08-30
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100382
  • 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
    Tracheostomy tube (w/wo connector) - Product Code BTO
  • Causa
    The product does not contain a punched hole above the cuff access port (a lumen that enables suctioning of secretions proximal to the inflated cuff) as intended by the devices design. this eliminates the user's ability to suction secretions through this suction port, necessitating that the user revert to standard of care methods for suctioning secretions from around the cuffed trach tube shaft.
  • Acción
    Arcadia Medical Corporation sent a "MEDICAL DEVICE RECALL" letter on May 9, 2011 and email on May 8, 2011 to all affected costumers. The letter included; description of the product name, afffected lot numbers, description of the problem, instructions to discontinue use of the recalled devices and to return them to Arcadia Medical for replacement . The letter instructed the customers to email Arcadia Medical with the number of devices in their inventory. For additional information contact Arcadia Medical Corporation at 219-779-9431.

Device

Device Recall Silicone CTS Tracheostomy Tube
  • Modelo / Serial
    Lots 00911114 Catalog # 180-060, and Lot 00911116 Catalog # 180-080
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution --USA including the state of Ohio, and the countries of Denmark, Italy, Germany, Turkey, Slovakia, Isreal, France, Sweden, and Romania
  • Descripción del producto
    Silicone CTS (Close to Shaft) Cuff Adjustable Neck Flange Tracheostomy Tube (Wire Reinforced), Arcadia Medical Silicone Air Cuff Adjustable Tracheostomy Tube, Sterile, Latex-Free, || Provides direct tracheal access for airway management || Arcadia Medical Corporation || 1450 East American Lane, Schaumburg, IL 60173 USA || Arcadia Medical Corporation Tortola, British Virgin Islands || www.arcadiamedical.com, Made in USA
  • Manufacturer
    Arcadia Medical Corporation

Manufacturer

Arcadia Medical Corporation
  • Dirección del fabricante
    Arcadia Medical Corporation, 1140 Millennium Dr, Crown Point IN 46307-7533
  • Source
    USFDA