Events

Retiro De Equipo (Recall) de Sheridan Preformed Cuffed Nasal Tracheal Tube 7.5 mm

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 Teleflex Medical.

¿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
    36426
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0128-2007
  • Fecha de publicación del evento
    2006-11-02
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2009-08-12
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48637
  • 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
    Tracheal Tube - Product Code BTR
  • Causa
    Biological indicator failed. investigation eliminated all equipment and product related factors.
  • Acción
    Teleflex Medical sent Urgent Medical Device Recall letters dated 9/27/06 via UPS overnight to the direct accounts, informing them that the product did not pass validated sterility test requirements, and requesting that they cease use of the affected units and return them to Teleflex Medical for replacement. If the accounts further distributed the product, they were requested to conduct a sub-recall of the affected units from their customers. The accounts were instructed to complete and return by fax the enclosed Acknowledgement & Stock Status Form, indicating the number of units being returned for replacement. Any questions were directed to Linda Todd at 1-800-334-9751, ext. 4951.

Device

Sheridan Preformed Cuffed Nasal Tracheal Tube 7.5 mm
  • Modelo / Serial
    catalog number (REF) 5-22315, lot number 1189026
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide and Argentina, Canada, Chile, Japan, Malaysia, the Netherlands and New Zealand
  • Descripción del producto
    Sheridan Preformed Cuffed Nasal Tracheal Tube, 7.5 mm; a Rx, sterile, single use tracheal tube; Hudson Respiratory Care Inc., Temecula, CA 92589-9020, Manufactured in Mexico; catalog number (REF) 5-22315
  • Manufacturer
    Teleflex Medical

Manufacturer

Teleflex Medical
  • Dirección del fabricante
    Teleflex Medical, 2345 Waukegan Rd Ste 120, Bannockburn IL 60015-1580
  • Source
    USFDA