Events

Retiro De Equipo (Recall) de Device Recall Pinnacle Destination Guiding Sheath, 6 French, 90 cm

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 Terumo 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
    58677
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2415-2011
  • Fecha de inicio del evento
    2010-06-24
  • Fecha de publicación del evento
    2011-06-06
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-07-07
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99892
  • 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
    Molding defect in destination product that render the device unusable.
  • Acción
    Terumo Medical Corporation sent an Urgent Product Bulletin Recall letter dated June 24, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Terumo requested customers to immediately discontinue use, and quarantine any available stock of the listed product codes. In order to facilitate the exchange of these devices, a Terumo Territory Manager contacted all customers by July 9th to confirm receipt of the Terumo Destination Bulletin and scheduled an appointment to visit each customer in person by July 31st to personally manage the exchange. For questions or for further information, call (800) 283-7866 and ask to speak with the Product Recall Coordinator.

Device

Device Recall Pinnacle Destination Guiding Sheath, 6 French, 90 cm
  • Modelo / Serial
    RSC01
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA including AL, AK, AZ, TX, LA, MS, MN, MO, CA, GA, FL, HI, KS, IA, ID, IL, TN, NM, OR, OK, WA, and WI and the countries of Belgium, Brazil, and Panama
  • Descripción del producto
    Pinnacle Destination Guiding Sheath, 6 French, 90 cm, Straight Tip, Tuohy-Borst Valve, Lot MD24, MD31, ME07, & ME14. 510(k) K012812 || Guiding Sheath is used to facilitate the introduction of interventional and diagnostic devices into the human vasculature, including but not limited to the renal arteries for the Renal Guiding Sheath and the carotid arteries for the Carotid Guiding Sheath.
  • Manufacturer
    Terumo Medical Corporation

Manufacturer

Terumo Medical Corporation
  • Dirección del fabricante
    Terumo Medical Corporation, 950 Elkton Blvd, Elkton MD 21921-5322
  • Empresa matriz del fabricante (2017)
    Terumo Corp.
  • Source
    USFDA