Events

Retiro De Equipo (Recall) de Device Recall EKOS EkoSonic Endovascular Device

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 EKOS 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
    73195
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0864-2016
  • Fecha de inicio del evento
    2016-01-21
  • Fecha de publicación del evento
    2016-02-24
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-03-15
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143565
  • 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
    Catheter, continuous flush - Product Code KRA
  • Causa
    The ekosonic kit, including the individually labeled microsonic device (msd) and intelligent drug delivery catheter (iddc) are labeled with a 135 cm working length, and programmed with a 135 cm family code, however the msd actual working length is 106 cm.
  • Acción
    All affected consignees were contacted by telephone January 20- 22, 2016. The URGENT  VOLUNTARY PRODUCT RECALL letter, dated January 21, 2016, was sent to consignees. Consignees were advised that replacement devices were shipped to their facility on January 21, 2016 and should arrive there on January 22, 2016. Consignees with questions can call: Jocelyn Kersten Vice President, Regulatory and Clinical Affairs EKOS Corporation, a BTG International Group Company 425-415-3132 Jocelyn.kersten@ekoscorp.com

Device

Device Recall EKOS EkoSonic Endovascular Device
  • Modelo / Serial
    Lot Number 150910004. Expiration date is August 15, 2018.  Serial numbers: 001, 002, 003, 004, 005, 006, 007, 008, 009, 010
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distributed in the states of AZ, CA, MA, MI, OH, and VA.
  • Descripción del producto
    EkoSonic Endovascular System, Catalog Number 500-56112. || It consists of three main components, a single use EkoSonic Endovascular Device which is comprised of an Intelligent Drug Delivery Catheter (IDDC) and removable MicroSonic Device (MSD), and a reusable EKOS EkoSonic Control System. || During use, fluids are delivered through the side-holes of the IDDC. The MSD is placed through the central lumen of the IDDC to deliver ultrasound energy along the length of fluid delivery, dispersing the fluid into the intravascular treatment site. || The reusable EKOS EkoSonic Control Unit provides power to the system and the user interface for operator control. A reusable, non-sterile Connector Interface || Cable connects the EKOS EkoSonic Control Unit to the EkoSonic Endovascular Device.
  • Manufacturer
    EKOS Corporation

Manufacturer

EKOS Corporation
  • Dirección del fabricante
    EKOS Corporation, 11911 N Creek Pkwy S, Bothell WA 98011-8809
  • Empresa matriz del fabricante (2017)
    Btg Plc
  • Source
    USFDA