Events

Retiro De Equipo (Recall) de Device Recall St Jude Medica CPS Direct SL

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 St Jude Medical CRMD.

¿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
    37818
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0933-2007
  • Fecha de inicio del evento
    2007-03-20
  • Fecha de publicación del evento
    2007-06-14
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-02-29
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=51612
  • 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
    Slittable CRT lead delivery tool - Product Code MCX
  • Causa
    Device separation- product may separate at the mapping collar transition joint located at the proximal (light blue) marker band end of the tool during the implant procedure.
  • Acción
    By Letter dated March 20, 2007, customers were requested to returned affected product immediately to St. Jude Medical. St. Judes Sales Representative will be assisting customers in retrieving the subject inventory from their shelves. The firm instructed customers that if they should require further information regarding this issue, to contact the firm's Technical Service department at (800) 722-3774 or customers can contact local St. Jude Medical representative.

Device

Device Recall St Jude Medica CPS Direct SL
  • Modelo / Serial
    Models: CPS Direct SL (Models 410110; 410111; 410112; 410113; 410114; 410115; 410116; 410120; 410121; 410122; 410123; 410124; 410126).  CODE INFORMATION: All devices with sterile lot numbers beginning with S, CR, or any C4 lot numbers starting with CP 05274 or higher.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    Worldwide-including states of AZ, CA DC, FL GA, IN, KS, LA, MA, MD, ME, MI, MN, MS, NC, NH, NY, OH, PA, RI, TN, VA, and WI and countries of Austria, Belgium, Denmark, Finland, Netherlands, Sweden, France, Germany, Italy, UK, Spain, Portugal, Poland, Switzerland, Australia, New Zealand, Thailand, Hong Kong, Korea, Malaysia and Singapore.
  • Descripción del producto
    St. Jude Medical-CPS Direct SL- slittable CRT lead delivery tool. -Model Numbers 410110, 410111, 410112, 410113, 410114, 410115, 410116, 410120,410121. 410122, 410123, 410124, 410125 and 410126.
  • Manufacturer
    St Jude Medical CRMD

Manufacturer

St Jude Medical CRMD
  • Dirección del fabricante
    St Jude Medical CRMD, 15900 Valley View Ct, Sylmar CA 91342-3577
  • Source
    USFDA