Events

Retiro De Equipo (Recall) de Device Recall CAPIOX Flexible Venous Reservoir

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 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
    59454
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2950-2011
  • Fecha de inicio del evento
    2011-07-21
  • Fecha de publicación del evento
    2011-08-04
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-02-10
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102828
  • 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
    Reservoir, blood, cardiopulmonary bypass - Product Code DTN
  • Causa
    Reservoir blood bag used in cardiovascular procedures may leak.
  • Acción
    Terumo Cardiovascular Systems Corporation sent an "URGENT MEDICAL DEVICE REMOVAL" letter dated July 20, 2011, to all affected consignee. The letter described the problem, the potential hazard, and the actions to be taken. The letter instructed customers to identify affected inventory and segregate from non-affected product. The recalling firm advises users to not use affected product and return for replacement. The customers are instructed to call the recalling firm Customer Service for a Returned Goods Authorization (RGA) number. Customers were asked to complete the attached Response Form and return as per the instructions. Consignees with questions should call 1-800-521-2818 Monday through Friday 8AM to 6PM EST.

Device

Device Recall CAPIOX Flexible Venous Reservoir
  • Modelo / Serial
    CAPIOX Flexible Venous Reservoir, Lot NE13, (used as single units) or as a component in sterilized custom cardiovascular procedure kits with kit lot numbers NC21 R, ND21 R, NF02, and NF02.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    (USA) Nationwide Distribution including states of: FL, MI, MT, NY, TN and VA.
  • Descripción del producto
    CAPIOX¿ Flexible Venous Reservoirs, 1500 mL, product codes: CXFVR1500X and CXFVRI500XC, used singly or packaged as components in cardiovascular procedure trays labeled in part ***Terumo Caerdiovascular Systems Corporation, Elkton, MD 21921*** || Product Usage: The reservoir bag is intended for use as a blood collection and storage device during cardiopulmonary bypass procedures. The device is intended for use in conjunction with blood-gas oxygenators in the extra-corporeal circuit. The device may be used in procedures lasting up to 6 hours.
  • Manufacturer
    Terumo Cardiovascular Corporation

Manufacturer

Terumo Cardiovascular Corporation
  • Dirección del fabricante
    Terumo Cardiovascular Corporation, 125 Blue Ball Rd, Elkton MD 21921-5315
  • Empresa matriz del fabricante (2017)
    Terumo Corp.
  • Source
    USFDA