Events

Retiro De Equipo (Recall) de Asahi KASEI, REXEED(TM) 21 SX, HEMODIALYZER

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 Asahi Kasei Medical Co., Ltd., Okatomi Plant.

¿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
    63146
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2420-2012
  • Fecha de inicio del evento
    2012-09-21
  • Fecha de publicación del evento
    2012-09-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-02-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112683
  • 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
    Dialyzer, high permeability with or without sealed dialysate system - Product Code KDI
  • Causa
    Asahi became aware of a negative trend for rate of the adverse events that may be associated with a manufacturing change to certain lot numbers of the products, though there is no sufficient information to date to conclusively link these adverse events to the products.
  • Acción
    AsahiKASEI Medical Co., LTD sent a Medical DeviceRecall letter on September 21, 2012. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to confirm that they have no inventory and to forward the letter to all clinics who may have received the product requesting they check their stock and arrange for the return of any recalled product. Non-responding consignees will be contacted by telephone. For questions regarding this recall call Asaki Kasei Medical America, Inc. at 888-362-6105.

Device

Asahi KASEI, REXEED(TM) 21 SX, HEMODIALYZER
  • Modelo / Serial
    Lot numbers: 193J3R, 193M3T, and 294Q57
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    REXEED SX: Worldwide Distribution - USA including TN and the countries of Japan and Germany REXEED LX: Worldwide Distribution - USA including TN and Germany
  • Descripción del producto
    Asahi KASEI, REXEED(TM)- 21 SX, HEMODIALYZER || dialysis filter
  • Manufacturer
    Asahi Kasei Medical Co., Ltd., Okatomi Plant

Manufacturer

Asahi Kasei Medical Co., Ltd., Okatomi Plant
  • Dirección del fabricante
    Asahi Kasei Medical Co., Ltd., Okatomi Plant, 4960 5 Chome Nakagawara Cho, Nobeoka-shi Japan
  • Empresa matriz del fabricante (2017)
    Asahi Kasei Corp.
  • Source
    USFDA