Events

Retiro De Equipo (Recall) de Device Recall Evolution steam sterilizers

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 Steris Corporation.

¿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
    61786
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1522-2012
  • Fecha de inicio del evento
    2012-03-23
  • Fecha de publicación del evento
    2012-05-11
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-06-11
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109080
  • 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, steam - Product Code FLE
  • Causa
    Through customer feedback and field service experience, steris learned that operators may experience difficulty when inserting or removing equipment from the evolution sterilizer using the transfer carriage due to the following issues with the transfer carriage. 1) deformation of the latch pin or cracked ball bearings preventing the roller from turning. 2) the rollers on the ends of the pivot a.
  • Acción
    Steris Corporation sent an Urgent Voluntary Field Correction Notice dated March 23, 2012 via FedEx with tracking numbers for delivery confirmation to each affected customer. The letter identified the affected product, problem and actions to be taken. The letter stated a STERIS Field Service Representatives will contact each affected customer to schedule a service visit to upgrade the transfer carriages. For technical questions or questions regarding STERIS visit to your facility, please contact STERIS Field Service Dispatch at 1-800-333-8828.

Device

Device Recall Evolution steam sterilizers
  • Modelo / Serial
    Model #: M4012097, M4012098, M4011084, M4011085 & M4011090; Seral #s: 030400905 thru 030381235.
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA Nationwide including AL, AZ, CA, CO, CN, DE, FL, GA, IL, IN, KA, KY, LA, MD, MA, MI, ME, MO, MT, NE, NH, NJ, NM, NY, NC, ND, OH, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, & WY and the countries of Brazil and Canada.
  • Descripción del producto
    The Evolution steam sterilizers, manufactured by Steris Corporation, utilize a loading system to assist the operator in transporting, loading and unloading items to be sterilized. It consists of two major components: || -Loading Car: Shelving unit which holds the items to be sterilized; and the || -Transfer Carriage: Wheeled unit which loads/unloads the loading car and transports it from one location to another. Product shipped in crate. || Product Usage: || The Evolution Transfer Carriage is a wheeled unit which loads/unloads the sterilizer loading car and transports it from one location to another.
  • Manufacturer
    Steris Corporation

Manufacturer

Steris Corporation
  • Dirección del fabricante
    Steris Corporation, 5960 Heisley Rd, Mentor OH 44060-1834
  • Empresa matriz del fabricante (2017)
    Steris Corporation
  • Source
    USFDA