Events

Retiro De Equipo (Recall) de Device Recall Cellex Photopheresis 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 Therakos 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
    73012
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1322-2016
  • Fecha de inicio del evento
    2015-12-21
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-10-14
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142725
  • 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
    System, photopheresis, extracorporeal - Product Code LNR
  • Causa
    The mallinckrodt (therakos) post-market monitoring process detected an increased trend in tubing leaks within the pump tubing organizer, associated with a portion of kits from lot d 342.
  • Acción
    Therakos sent an Urgent Medical Device Recall letter dated December 23, 2015, to all affected customers by UPS Overnight Mail. The letter identified the product, the problem, and the action to be taken by the customer. The consignees were instructed to immediately identify, discontinue use and return affected product. Customers with questions were instructed to call Therakos Customer Service at 1-855-422-9115, option 4. For questions regarding this recall call 908-238-6813.

Device

Device Recall Cellex Photopheresis System
  • Modelo / Serial
    Mfr lot #D342
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution to AL, AZ, CA, CO, DC, FL, ID, IL, IN, MA, ME, MN, MO, NC, NJ, NY, OH, PA, SC, TN, TX, UT, VT, AND WI.
  • Descripción del producto
    The THERAKOS CELLEX Photopheresis System is a photoimmune therapy. Catalog CLXUSA. || Manufacturing lot D342 || UDI: 20705030200003 || The system designed to separate the patient's blood into various fractions and collect the white blood cell (WBC) fraction. The WBC fraction is treated with a photoactive drug UVADEX¿ (methoxsalen) Sterile Solution. The UVADEX is photo-activated by UVA light and results in the WBCs undergoing apoptosis
  • Manufacturer
    Therakos Inc

Manufacturer

Therakos Inc
  • Dirección del fabricante
    Therakos Inc, 10 N High St, West Chester PA 19380-3003
  • Empresa matriz del fabricante (2017)
    Mallinckrodt Plc
  • Source
    USFDA