Events

Retiro De Equipo (Recall) de Arstasls One Access System

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 Arstasis, 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
    57507
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-0993-2011
  • Fecha de inicio del evento
    2010-10-19
  • Fecha de publicación del evento
    2011-02-04
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-02-16
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96420
  • 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
    Introducer, catheter - Product Code DYB
  • Causa
    Device has the potential to fracture and sheath separation during use.
  • Acción
    The firm, Arstasis, initiated a market withdrawal and sent notification via letters dated October 19, 2010, to customers informing the customers that Arstasis is implementing a product improvement and will replace all existing inventory that the customer has on their shelf with the improved product. The customers were instructed to work closely with their local Arstasis territory manager to ensure that their product replacement is handled satisfactorily, and complete and return the PRODUCT REPLACEMENT and PRODUCT RETURN forms to Arstasis Customer Service via fax at 1-877-688-8417 or email to customerservice@arstasis.com. If you have any questions or concerns, contact Customer Service toll free at 1-877-594-4545.

Device

Arstasls One Access System
  • Modelo / Serial
    Lot Numbers: 09I10268, 1OC26337, 09J06281, 10C12334
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution
  • Descripción del producto
    Arstasls One Access System; Models: AAD100, AAD101, Part Numbers: FG-02279, FG-03010; The system consists of the following components: (1) Device Sheath/Anchor, (2) Shaft || and (3) Handle with control features. Product is manufactured and distributed by Arstasis Inc., San Carlos, CA || The Arstasis One Access System is a sterile, single use system intended to provide access for the percutaneous introduction of devices into the peripheral vasculature and to promote hemostasis at the arteriotomy site as an adjunct to manual compression. The System is Indicated for use in patients undergoing diagnostic femoral artery catheterization procedures using SF or 6F Introducer sheaths.
  • Manufacturer
    Arstasis, Inc

Manufacturer

Arstasis, Inc
  • Dirección del fabricante
    Arstasis, Inc, 740 Bay Rd, Redwood City CA 94063-2469
  • Empresa matriz del fabricante (2017)
    Arstasis Inc.
  • Source
    USFDA