Events

Retiro De Equipo (Recall) de Device Recall Terumo Cardiovascular Systems (CVS)

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 Cardiovascular Systems Corp.

¿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
    72010
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2788-2015
  • Fecha de inicio del evento
    2015-08-24
  • Fecha de publicación del evento
    2015-09-18
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-02-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139619
  • 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 and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • Notas adicionales en la data
    unknown device name - Product Code N/A
  • Causa
    Custom cardiovascular procedure kits contain recalled component medivators hph700 high performance hemoconcentrators.
  • Acción
    Terumo CVS issued an Urgent Medical Device Recall Notice dated August 24, 2015, to consignees via express mail. The letter advised users to immediately quarantine affected Cardiovascular Procedure Kits and stop using the Hemocor HPH700 Hemoconcentrator within the kit. Replacement sterile, stand-alone Hemocor HPH700 Hemoconcentrators will accompany the letter so that users may replace the affected emoconcentrators at the point of use. The option of replacing the hemoconcentrator at the point of use is offered to facilitate imminently scheduled cardiopulmonary bypass procedures. Users are requested to return the unused hemoconcentrators to Terumo CVS. Alternatively, users may return the entire Cardiovascular Procedure Kit to Terumo CVS for replacement. Customers with questions were instructed to call 763-553-3348.

Device

Device Recall Terumo Cardiovascular Systems (CVS)
  • Modelo / Serial
    Lot Numbers: TD02, TD16
  • Distribución
    Nationwide Distribution including CA, CT , FL , WI.
  • Descripción del producto
    Terumo Custom Cardiovascular Procedure Kit X-Coated Perfusion Pack with FX25RE || P/N: 7928-03 || Terumo Cardiovascular Procedure Kits are manufactured and customized to the design and specifications of the purchaser and/or the purchaser's principal technical representative for the application intended by the end user. The kits are comprised of a variety of legally marketed medical devices [including Medivators HPH700 High Performance Hemoconcentrators]. The Hemocor HPH700 Hemoconcentrator is intended for use as an ultrafiltration system to remove excess fluid during and/or following cardiopulmonary bypass procedures where acute hemodilution has been employed
  • Manufacturer
    Terumo Cardiovascular Systems Corp

Manufacturer

Terumo Cardiovascular Systems Corp
  • Dirección del fabricante
    Terumo Cardiovascular Systems Corp, 28 Howe St, Ashland MA 01721-1305
  • Empresa matriz del fabricante (2017)
    Terumo Corp.
  • Source
    USFDA