Events

Retiro De Equipo (Recall) de Device Recall PINNACLE Introducer Sheath

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
    73833
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2738-2016
  • Fecha de inicio del evento
    2016-03-16
  • Fecha de publicación del evento
    2016-09-06
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-01-27
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=145071
  • 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
    Terumo medical is initiating this recall due to complaints of valve leakage that have been related to a manufacturing issue. if affected introducer sheaths are used, there is possible risk of incremental blood loss through the valve.
  • Acción
    Terumo sent an Urgent Product Recall Bulletin dated March 7, 2016, to all affected customers. All affected customers will be notified regarding the required recall actions (stop using/quarantine the affected products). TMC will strive for 100% verification to confirm that all customers have acknowledged the recall. Follow-up communication is being sent specifying the mechanisms to be used for labeling and returning the involved product from the customer level. We regret any inconvenience this action may cause your operations and we appreciate your understanding. Please contact us if you need assistance procuring additional inventory. We are committed to continuing to offer products that meet the highest quality standards that you expect from Terumo Medical Corporation. If you have questions or need further information, please call Customer Care at 1-800-888-3786 or contact your local sales representative. For further questions regarding this recall please call (410) 392-7226.

Device

Device Recall PINNACLE Introducer Sheath
  • Modelo / Serial
    Please see Attachment 3
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution
  • Descripción del producto
    PINNACLE¿ Introducer Sheath || PINNACLE PRECISION ACCESS SYSTEM¿ Sheath || PINNACLE¿ TIF TIP" Introducer Sheath || PINNACLE¿ R/O II Radiopaque Marker Introducer 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