Events

Retiro De Equipo (Recall) de Device Recall CryoValve Allograft

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 Cryolife 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
    25635
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0673-03
  • Fecha de inicio del evento
    2003-02-18
  • Fecha de publicación del evento
    2003-03-21
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2003-07-21
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=26186
  • 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
    Heart-Valve, Allograft - Product Code MIE
  • Causa
    Microorganisms were detected in distributed donor tissue.
  • Acción
    Medical facilities were contacted by CryoLife Technical Representatives via letter on/about 2/20/2003 to alert the facility of the removal and to determine the disposition of the allografts. Firms were advised, if the tissue has not been implanted, not to implant or distribute the tissue and to place it into quarantine. Consignees were to contact CryoLife''s Regulatory Affairs Department-Field Assurance, and a representative would issue a Return Materials Authorization number and will provide specific instructions for returning the tissue. There is a stamped, self addressed postcard attached to affirm receipt of the notification.

Device

Device Recall CryoValve Allograft
  • Modelo / Serial
    Donor #61266, Serial # 7701969, Model #AV00; Donor #63307, Serial #7899279, Model # SGAV00; Donor #64489, Serial #7869356, Model # SGPV00; Donor #65674, Serial # 7957300 Model #SGPV00; Donor #64879, Serial # 7883273, Model #SGPV00; Donor #64697, Serial #7876274, Model #PV00.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Tissue products were distributed to Medical facilities located in CA, MD, ME and SD. There were no foreign or government accounts.
  • Descripción del producto
    CryoValve Allograft, heart valve
  • Manufacturer
    Cryolife Inc

Manufacturer

Cryolife Inc
  • Dirección del fabricante
    Cryolife Inc, 1655 Roberts Blvd Nw, Kennesaw GA 30144
  • Source
    USFDA