Events

Retiro De Equipo (Recall) de Device Recall Infinity sampling device, Cytology Brush

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 US Endoscopy Group 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
    63047
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2396-2012
  • Fecha de inicio del evento
    2011-12-22
  • Fecha de publicación del evento
    2012-09-17
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-03-22
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112365
  • 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 and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • Notas adicionales en la data
    Endoscope and/or accessories - Product Code KOG
  • Causa
    Us endoscopy received five complaints which noted difficulty in deploying the cytology brush through the catheter.
  • Acción
    US Endoscopy sent an Addendum and Correction to the Instructions for Use letter dated December 22, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to rinse the brush head with sterile water immediately prior to use (reference the attached Addendum. Customers were also instructed to retract and deploy the brush to ensure that is is functioning properly prior to use. Customers were asked to review the instruction for use for this product along with the Addendum to ensure proper usage and performance. For questions customers should call 1-410-639-4494 or their local Endoscopic Product Specialist. For questions regarding this recall call 440-639-4494, ext 378.

Device

Device Recall Infinity sampling device, Cytology Brush
  • Modelo / Serial
    Lot numbers 49680, 50793, 50794, 50795, 52577 & 53023.
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA including CA, FL, GA, IA, IL, MA, ME, MN, MO, NC, NH, OH, OK, PA, TN, TX, VA, WA & WV and the countries of Australia, Canada, Columbia, Finland, Germany, India, Israel, Italy, Netherlands, New Zealand & United Kingdom.
  • Descripción del producto
    Infinity¿ sampling device, Cytology Brush, United States Endoscopy Group, Inc., 5976 Heisley Road, Mentor, OH 44060 || The Infinity sampling device is a disposable cytology brush used to retrieve cytological cell samples in the gastrointestinal tract.
  • Manufacturer
    US Endoscopy Group Inc

Manufacturer

US Endoscopy Group Inc
  • Dirección del fabricante
    US Endoscopy Group Inc, 5976 Heisley Rd, Mentor OH 44060-1873
  • Empresa matriz del fabricante (2017)
    Steris Plc
  • Source
    USFDA