Events

Retiro De Equipo (Recall) de Device Recall STERRAD 200 Sterilizer

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
    60889
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0741-2012
  • Fecha de inicio del evento
    2012-01-23
  • Fecha de publicación del evento
    2012-01-13
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-09-23
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106716
  • 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
    Sterilizer, chemical - Product Code MLR
  • Causa
    Asp determined that an internal filter in the vacuum pump on the sterrad 200 system is subject to wear over time.
  • Acción
    ASP will send an Urgent Medical Device Correction letter to all affected customers on January 23rd, 2012. The letter describes the product, problem and the actions to be taken. The letter informs customers that ASP has determined that the vacuum pump in the STERRAD 200 System may cause the emission of a slightly increased level of hydrogen peroxide (H2O2) vapor into the surrounding environment if not regularly serviced or replaced. The letter instructed customers to read the "Issue Description" and "Recommendations" sections in the letter, pass on the notice with any staff that work with or around the STERRAD 200, and maintain awareness of this communication until ASP has serviced the system. Also, a list of FAQ was provided. The letter states that ASP will replace, free of charge, the vacuum pumps on all STERRAD 200 Systems that have exceeded the pump manufacturer's recommended service interval. ASP has contracted with Stericycle to manage this field correction. Telephone numbers are provided in the letter: for questions related to this field correction, please contact Stericycle at 1-877-225-9750 and to report any complaints or suspected problems with the System, please contact ASP Professional Services directly at 1-888-783-7723, option # 2.

Device

Device Recall STERRAD 200 Sterilizer
  • Modelo / Serial
    Product Code 10201
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide)
  • Descripción del producto
    STERRAD 200 Sterilizer, Hydrogen Peroxide Gas Plasma Sterilizer, Chemical Sterilizer. STERRAD 200; Product Usage: The STERRAD Sterilization System is a low-temperature general-purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.
  • 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