Events

Retiro De Equipo (Recall) de Device Recall INSPIRE 6 hollow fiber oxygenator with integrated hardshell venous/cardiotomy 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 LivaNova USA.

¿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
    79863
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1918-2018
  • Fecha de inicio del evento
    2018-03-13
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=163774
  • 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
    Oxygenator, cardiopulmonary bypass - Product Code DTZ
  • Causa
    Some integrated sterile inspire family products contain an incorrect expiration date printed in the unique device identification (udi) bar code and readable code just beneath the barcode. specifically, the expiration date is reported as ddmmyy instead of yymmdd. the expiration date in the applicable field on the package labels are correct as printed.
  • Acción
    On March 13, 2018, notification letters were emailed. Customers were instructed to return response forms, which indicated the following: amount of unused product, and whether they would contact the firm to relabel effected products or if they preferred to be trained on the relabeling procedure. If product was further distributed, customers were instructed to send the notification letter to these additional customers within 2 business days. No action is required for product already used since it was consumed prior to the true expiration date. For further questions, please call (281) 228-7260.

Device

Device Recall INSPIRE 6 hollow fiber oxygenator with integrated hardshell venous/cardiotomy rese...
  • Modelo / Serial
    Lot: 1709190228, UDI: (01)08033178112352(17)200917(10)1709190228, Exp: 09/17/2020
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Distribution to the states of : NJ, CA, MN, MO, MA
  • Descripción del producto
    Inspire 6 Integrated Phisio OXY w/ HVR Reservoir, Sterile EO, Catalog # 050713 || The intended uses for the two elements that constitute the oxygenator/reservoir integrated devices are: INSPIRE 6M Hollow Fiber Oxygenator: The INSPIRE 6M is intended for use in adult and small adult surgical procedures requiring cardiopulmonary bypass. It provides gas exchange support and blood temperature control. The INSPIRE 6M is intended to be used for 6 hours or less. INSPIRE HVR (Hardshell Venous/Cardiotomy Reservoir): The INSPIRE HVR is intended for use in adult and small adult surgical procedures requiring cardiopulmonary bypass. It collects, de-foams and filters venous blood and suction blood. INSPIRE HVR can be used post-operatively for chest drainage. The INSPIRE HVR is intended to be used for 6 hours or less
  • Manufacturer
    LivaNova USA

Manufacturer

LivaNova USA
  • Dirección del fabricante
    LivaNova USA, 14401 W 65th Way, Arvada CO 80004-3503
  • Empresa matriz del fabricante (2017)
    LivaNova PLC
  • Source
    USFDA