Events

Retiro De Equipo (Recall) de Device Recall EvoTech Endoscope Cleaner & Reprocessor

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 Advanced Sterilization Products.

¿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
    46906
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1369-2008
  • Fecha de inicio del evento
    2008-02-13
  • Fecha de publicación del evento
    2008-08-08
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-11-29
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=68458
  • 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
    Endoscope Washer/Disinfector - Product Code FEB
  • Causa
    Cleaning cycles are being cancelled. specific issues are: a) water heater tank is rusting resulting in the in-line 0.2 micron filter prematurely clogging, b) interface board malfunction resulting in a premature lid opening, and c) minor fluid leaks within the system (commonly at the 0.2 micron filter attachment points).
  • Acción
    Feburary 13, 2008 ASP issued an Urgent Product Recall Letter. ASP recommends that customers use an alternative reprocessing method until they return the system. However, if they do not have an alternate method for processing endoscopes and choose to continue using the EvoTech ECR System during this time, endoscopes processed through completed cycles in accordance with the User's Guide will be appropriately cleaned and highlevel disinfected. ASP is prepared to tailor an alternative solution to minimize the interruption to the customer's processing needs.

Device

Device Recall EvoTech Endoscope Cleaner & Reprocessor
  • Modelo / Serial
    Product Code 50004-002; Serial Numbers 50004002070001 and 50004002070004
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution --- including USA and countries of Canada and Japan.
  • Descripción del producto
    EvoTech Endoscope Cleaner and Reprocessor, Product Code 50004-002 || Indicated for use with high level disinfectant CIDEX OPA Concentrate and an enzymatic detergent, CIDEZYME GI, to achieve cleaning and high level disinfection of heat sensitive semi-critical endoscopes.
  • Manufacturer
    Advanced Sterilization Products

Manufacturer

Advanced Sterilization Products
  • Dirección del fabricante
    Advanced Sterilization Products, 33 Technology Dr, Irvine CA 92618-2346
  • Empresa matriz del fabricante (2017)
    Johnson & Johnson
  • Source
    USFDA