Events

Retiro De Equipo (Recall) de Device Recall ASP Automatic Endoscope Reprocessor (AER)

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
    57281
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0628-2011
  • Fecha de inicio del evento
    2010-02-19
  • Fecha de publicación del evento
    2010-12-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-07-30
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95737
  • 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 and/or accessories - Product Code KOG
  • Causa
    The recall was initiated because advanced sterilization products (asp) received three customer reports of elevated temperature of the high-level disinfectant solution used in the asp aer as a result of a possible temperature monitoring system malfunction. this recall communication advised consignees that if high-level disinfectants are exposed to elevated temperatures, fumes may occur and resul.
  • Acción
    Advanced Sterilization Products sent an URGENT: PRODUCT CORRECTION letter dated February 19, 2010, to all customers. The letter identified the product, the problem, and the action to be taken by the customer. The recall communication was initiated with ASP forwarding a "Urgent: Product Correction" letter with attached customer fax-back response form to the affected customers. Customers were also instructed to complete and sign the enclosed customer fax-back response form indicating that they have disconnected the heater on the ASP AER according to the instructions provided and fax the form to 1-888-345-1435. If customers have any questions or need assistance, they were instructed to call ASP Professional Services at 888-783-7723, option 3 then option 1.

Device

Device Recall ASP Automatic Endoscope Reprocessor (AER)
  • Modelo / Serial
    Product Code: 20300 & 20301
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- United States, Argentina Brazil, Canada, Chile, Colombia, Costa Rica, Ecuador, Hungary, Mexico, Panama, Guatemala, Honduras, Poland, Puerto Rico, Virgin Islands, Singapore, Taiwan, Venezuela, Croatia, and Bulgaria.
  • Descripción del producto
    ASP Automatic Endoscope Reprocessor (AER), Product Code: 20300 & 20301 || The AER is a machine designed to automatically wash and high-level disinfect flexible, submersible fiberoptic or video endoscopes.
  • Manufacturer
    Advanced Sterilization Products

Manufacturer

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