Events

Retiro De Equipo (Recall) de Device Recall Therakos UVAR XTS Procedural Kits

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
    57912
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2067-2011
  • Fecha de inicio del evento
    2011-02-01
  • Fecha de publicación del evento
    2011-04-28
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-03-13
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97743
  • 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
    Extracorporeal Photopheresis System - Product Code LNR
  • Causa
    Therakos received an increased rate of complaints of centrifuge bowl leaks for certain lots of therakos uvar xts procedural kits (product code xt 125).
  • Acción
    Therakos notified all direct Therakos US and ex-US End Users and Distributor consignees via Federal Express courier with an Urgent Product Correction Notification, dated 2/1/2011. The letter identified the reason for recall along with the affected product. Customers were to immediately discontinue using and discard the identified affected lots of the product. Customers were to use alternative lots. In order to receive credit for the discarded product, customers were to complete the attached confirmation of receipt and destruction. If there were any questions, a question and answer section was provided but additional questions could be directed towards Therakos Customer Service Center at 1-800-828-6316, Option 2,1.

Device

Device Recall Therakos UVAR XTS Procedural Kits
  • Modelo / Serial
    Lots Y703 through Y707 and Y709 though Y726  Lot Number - Expiration Date Y703, 1/1/2015 Y704, 2/1/2015 Y705, 2/1/2015 Y706, 2/1/2015 Y707, 2/1/2015 Y709, 2/1/2015 Y710, 3/1/2015 Y711, 3/1/2015 Y712, 3/1/2015 Y713, 3/1/2015 Y714, 3/1/2015 Y715, 3/1/2015 Y716, 3/1/2015 Y717, 4/1/2015 Y718, 4/1/2015 Y719, 4/1/2015 Y720, 4/1/2015 Y721, 4/1/2015 Y722, 4/1/2015 Y723, 4/1/2015 Y724, 4/1/2015 Y725, 5/1/2015; and Y726, 5/1/2015.
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution
  • Descripción del producto
    Therakos UVAR XTS Procedural Kits || Is indicated for use in the ultraviolet-A (UVA) irradiation.
  • Manufacturer
    Therakos Inc

Manufacturer

Therakos Inc
  • Dirección del fabricante
    Therakos Inc, 1001 Us Highway 202, Raritan NJ 08869
  • Empresa matriz del fabricante (2017)
    Mallinckrodt Plc
  • Source
    USFDA