Events

Retiro De Equipo (Recall) de Device Recall IDEAL MAXPAC TOTAL SYSTEM

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 Medtronic 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
    54237
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0868-2010
  • Fecha de inicio del evento
    2009-12-14
  • Fecha de publicación del evento
    2010-02-26
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-04-20
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=87923
  • 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
    Cardiopulmonary bypass accessory equipment. - Product Code KRI
  • Causa
    Medtronic has identified a small number of autotransfusion one source kits and maxpac/total system lots with incorrect use before dates (ubd) on the outer kit package label. the ubd on the outer label of the kit/pack does not accurately reflect the ubd of the components within the kit/pack. for affected product, the outer label lists a date which may be later than the usb of the components inclu.
  • Acción
    Consignees were sent a Medtronic "Urgent Medical Device Recall Notice" dated December 14, 2009. The letter was addressed to "Valued Customer." The letter described the product and the problem and requested them to quarantine the product and to complete and sign the attached certificate, "Medtronic Recall Certificate (FCA 1002)." For additional information, contact the firm at 763-514-9605.

Device

Device Recall IDEAL MAXPAC TOTAL SYSTEM
  • Modelo / Serial
    Lot #: 1058285, 10059556, 1099512, 1106926, 1106983, 1001369.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    CA, CO, JAPAN, CHINA.
  • Descripción del producto
    IDEAL MAXPAC TOTAL SYSTEM (USA) , Sterile and Nonpyrogenic, ETO or Gamma Sterilized, Medtronic Perfusion Systems, Model TS9453R29, TS9453R30, TS1470R1, TS1442R1, TS9800R32, TS8299R4.
  • Manufacturer
    Medtronic Inc

Manufacturer

Medtronic Inc
  • Dirección del fabricante
    Medtronic Inc, 710 Medtronic Pkwy, Minneapolis MN 55432-5603
  • Empresa matriz del fabricante (2017)
    Medtronic plc
  • Comentario del fabricante
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA