Events

Retiro De Equipo (Recall) de Device Recall Therakos 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
    55300
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1654-2010
  • Fecha de inicio del evento
    2010-03-29
  • Fecha de publicación del evento
    2010-05-26
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-07-18
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90508
  • 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
    photopheresis kit - Product Code LNR
  • Causa
    Higher than normal blood leaks on therakos cellex procedural kits that are intended for use with the therakos cellex photopheresis system.
  • Acción
    On March 29, 2010, Therakos Photopheresis sent Important Product Correction Notification letters by FedEx to all direct end use and distributor customers who received lot X120 in addition to phone contact. On March 31, 2010 those who received lot X123 were sent letters by Fed Ex as well as phone contact.. The one Canadian customer was notified by phone on March 31, 2010 followed by a Fed Ex letter. On April 12, consignees who were shipped Lot X119 were contacted by phone, followed by a hard copy letter. On May 7, 2010 all direct end use and distributor consignees were notified of the additional lot being added to the recall. Questions may be directed to Therakos Customer Technical Services at 1-877-865-6850.

Device

Device Recall Therakos CellEx Photopheresis System
  • Modelo / Serial
    CLXUSA (US): Lot X120, Exp 12/10; X123, Exp 1/2011; Lot Y106, Exp 2/1/11. CLSECP (For European Union), Lot X119, Exp 12/2014; Lot X123; Exp 1/2015
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution, and Canada and Germany
  • Descripción del producto
    Therakos CellEx Photopheresis System; || Photopheresis Procedural Kits, for use with the THERAKOS CellEx Instrument;
  • 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