Events

Retiro De Equipo (Recall) de Device Recall AMICUS Exchange Kit

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 Fenwal 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
    65296
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1523-2013
  • Fecha de inicio del evento
    2013-05-24
  • Fecha de publicación del evento
    2013-06-08
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-08-01
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118494
  • 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
    Separator, automated, blood cell and plasma, therapeutic - Product Code LKN
  • Causa
    Fenwal has initiated a voluntary urgent product recall for lot fa12c07070 of product code r4r2339, amicus exchange kits. fenwal identified a labeling issue with this batch of product code r4r2339 (which was cleared for european use only) in which this batch was distributed within the united states market. the problem is identified as labeling that did not include the written description for the s.
  • Acción
    Fenwal sent an Urgent Product Recall letter dated May 24, 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to immediately check inventory, discontinue the use of this prod.uct, return the affected product to Fenwal, and complete and return the attached reply form. For questions call 1-800-333-6925.

Device

Device Recall AMICUS Exchange Kit
  • Modelo / Serial
    Model No.: R4R2339;  Lot No.: FA12C07070;  Expiration Date: 03/2014
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    USA Nationwide Distribution
  • Descripción del producto
    AMICUS Exchange Kit; || Product Usage: || This kit is designed for use with the AMICUS separator for the Therapeutic Plasma Exchange (TPE) procedure. Sterilized by irradiation. Sterile fluid path. Non-pyrogenic fluid path.
  • Manufacturer
    Fenwal Inc

Manufacturer

Fenwal Inc
  • Dirección del fabricante
    Fenwal Inc, 3 Corporate Dr Ste 300, Lake Zurich IL 60047-8930
  • Empresa matriz del fabricante (2017)
    Fresenius SE & Co. KGaA
  • Source
    USFDA