Events

Retiro De Equipo (Recall) de Asahi APS Series MultipleUse Hollow Fiber Dialyzers

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 Medical Co., Ltd.

¿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
    36430
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0171-2007
  • Fecha de inicio del evento
    2006-10-12
  • Fecha de publicación del evento
    2006-11-14
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2007-11-28
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48642
  • 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
    Hollow Fiber Dialyzers - Product Code KDI
  • Causa
    There have been reports of difficulty separating the gambro cartridge blood set from asahi reuse/multiple use dialyzers at the end of treatment, possibly damaging the dialyzer nozzle.
  • Acción
    Asahi sent Safety Alert letters on 10/12/06 to their re-use dialyzer customers advising them of the reports of difficulty separating the blood set from the dialyzer and not to use the Gambro Cartridge Blood Set with Asahi Reuse/Multiple Use Dialyzers in a reuse situation. Enclosed were copies of the temporary revision Instructions For Use with the following warning added at the top of the page: 'Additional Warning for Reuse/Multiple Use Dialyzers: Ashai Reuse/Multiple use dialyzers must not be used in connection with the Gambro cartridge Blood Set in a reuse environment.' Any questions were directed to Karen Borling, RN at 847-498-8500.

Device

Asahi APS Series MultipleUse Hollow Fiber Dialyzers
  • Modelo / Serial
    Model APS-18R, Model APS-900S, Model APS-21R and APS-1050S, all lots
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide
  • Descripción del producto
    Asahi APS Series Multiple-Use Hollow Fiber Dialyzers; a wet model multiple use dialyzer consisting of hollow fiber membranes of polysulfone housed within a plastic casing of styrene butadiene block polymer, filled at the factory with fluid to facilitate priming by the user, and sterilized by gamma radiation before shipment; Asahi Medical Co., Ltd., 9-1, Kanda Mitoshirocho, Chiyoda-ku, Tokyo 101-8482, Japan; Made in Japan; 12 units per case; Models APS-18R and APS-900S - 1.8 m2 surface area, Model APS-21R and APS-1050S - 2.1 m2 surface area
  • Manufacturer
    Asahi Medical Co., Ltd

Manufacturer

Asahi Medical Co., Ltd
  • Dirección del fabricante
    Asahi Medical Co., Ltd, 3100 Dundee Rd Ste 201/202, Northbrook IL 60062-2437
  • Source
    USFDA