Events

Retiro De Equipo (Recall) de Device Recall BBB3872

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 Circulatory Technology 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
    74991
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2832-2016
  • Fecha de inicio del evento
    2016-07-01
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2018-06-14
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149041
  • 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
    The seal between the balloon and the housing may leak.
  • Acción
    The firm, Circulatory Technology Inc., sent an amended "Urgent: Expanded Device Recall" letter dated July 1, 2016, and response form to their customers via email. The letter described the product, problem and actions to be taken. The customers were instructed to immediately inspect their inventory, quarantine and prepare to ship the product back to Circulatory Technology Inc. Customers were also instructed to complete and return the response form via email to ytamari@cirtec.com. Customers with questions can call 516-624-2424, Monday through Friday 9:00 AM - 7:00 PM, EST.

Device

Device Recall BBB3872
  • Modelo / Serial
    Lot # 014648 USE BY: 09/01/2018
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Distribution to states of: LA, MI, NY, OH, OR & TX.
  • Descripción del producto
    The Bigger-Better-Bladder, TM 2 With 3/8"ID tubing, 72" long tubing, ITEM BBB38-72 || A device that isolates pressure tranducers from blood contact when measurements of blood pressure in extracorporeal circuits are made during short and long term procedures. The pressure signal can be used to control pump speed. It is also used as an inline reservoir to provide compliance in the circuit during short and long term procedures. Measures pressure noninvasively in the extracorporeal circuit and provide compliance in the venous line between the patient and the pump.
  • Manufacturer
    Circulatory Technology Inc

Manufacturer

Circulatory Technology Inc
  • Dirección del fabricante
    Circulatory Technology Inc, 21 Singworth St, Oyster Bay NY 11771-3703
  • Empresa matriz del fabricante (2017)
    Circulatory Technology Inc
  • Source
    USFDA