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
    58744
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2994-2011
  • Fecha de inicio del evento
    2011-03-31
  • Fecha de publicación del evento
    2011-08-10
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-03-18
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100212
  • 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
    Increased complaints were received of tubing leaks at the junction between the tubing and fluid logic module plastic ports of the kits.
  • Acción
    The firm, Therakos Photopheresis, sent a "URGENT PRODUCT CORRECTION NOTIFICATION" letter dated March 31, 2011 to its customers. The letter described the product, problem, and actions to be taken. The customers were instructed to immediately discontinue using the affected products; deface and discard their remaining inventory of affected procedural kits, following their internal procedures for destroying and discarding of medical waste, and complete and return the attached Confirmation of Receipt Form no later than 08-April-2011 via fax to: Safety, Risk Management and Surveillance at 1-888-557-3759 or 1-585-453-4110. If you have any additional technical questions, please contact Therakos Customer Service Center at 1-800-828-6316. If you have technical questions regarding this communication, please call Therakos Technical Support at 1-877-865-6850.

Device

Device Recall THERAKOS UVAR XTS Procedural Kits
  • Modelo / Serial
    XT125 Procedural Kit (X752-X760 and Y701-Y753) and XT001 Procedural Kit (X919 and Y901-Y911)
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA (nationwide) including states of: AK, AL, AR, AZ, CA, CO, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD,TN, TX, UT, VA, VT, WA, and WI; and countries of: Argentina, Austria, Australia, Belgium, Canada, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Korea, Kingdom of Saudi Arabia, Jordan, Netherlands, Norway, Philippines, Poland, Portugal, Russia, Singapore, Spain, Sweden, Switzerland, Turkey and United Kingdom.
  • Descripción del producto
    XT125 PHOTOPHERESIS PROCEDURAL KIT FOR USE WITH THE UVAR XTS INSTRUMENT; XT001 PHOTOPHERESIS PROCEDURAL KIT FOR USE WITH THE UVAR XTS INSTRUMENT || Single-use, disposable, closed system with sterile fluid pathways. The device collects the buffy coat (leukocyte-enriched blood) from the patient in a discontinuous flow process and intermittenly returns the remaining plasma and erythocytes to the patient.
  • Manufacturer
    Therakos, Inc.

Manufacturer

Therakos, Inc.
  • Dirección del fabricante
    Therakos, Inc., 440 Us Highway 22 Ste 140, Bridgewater NJ 08807-2477
  • Empresa matriz del fabricante (2017)
    Mallinckrodt Plc
  • Source
    USFDA