Events

Retiro De Equipo (Recall) de Device Recall Distal Access Catheter (DAC)

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 Concentric Medical 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
    72247
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0116-2016
  • Fecha de inicio del evento
    2015-08-19
  • Fecha de publicación del evento
    2015-10-09
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-10-09
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=140343
  • 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, percutaneous - Product Code DQY
  • Causa
    One distal access catheter intended for distribution in korea, was found at a us location.
  • Acción
    Issue was discovered by a sales representative during a visit for a case in Kentucky, where multiple Distal Access Catheters (DAC's) were being used. It was noticed that the reference number on one DAC carton did not match, even through the product labeling appeared to be the same. The mismatched unit was removed and returned to Concentric (Stryker). A formal recall letter was not issued as the product was returned after discovery. For further questions please call (510) 413-2263.

Device

Device Recall Distal Access Catheter (DAC)
  • Modelo / Serial
    Lot no. 37603 Expiration date: September 2016
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Distribution to one location in KY.
  • Descripción del producto
    Distal Access Catheters - 044 - 115 cm: || Finished Good Number 90960-001 / REF 90960. || Cardiology: The Distal Access Catheter is indicated for use in facilitating the insertion and guidance of an occlusion catheter, infusion catheter, or other appropriate microcatheter into a selected blood vessel in the peripheral, coronary and neuro vasculatuure systems.
  • Manufacturer
    Concentric Medical Inc

Manufacturer

Concentric Medical Inc
  • Dirección del fabricante
    Concentric Medical Inc, 301 E Evelyn Ave, Mountain View CA 94041-1530
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    USFDA