Events

Retiro De Equipo (Recall) de Biotene Moisturizing Mouth Spray

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 GlaxoSmithKline, LLC..

¿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
    66689
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0272-2014
  • Fecha de inicio del evento
    2013-10-17
  • Fecha de publicación del evento
    2013-11-13
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-07-26
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122970
  • 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
    Saliva, artificial - Product Code LFD
  • Causa
    Label indicates, "sweetened with xylitol and sorbitol", however product does not contain sorbitol.
  • Acción
    GlaxoSmithKline sent an Urgent Medical Device Recall letter dated October 17, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to return all affected product. If product was further distributed customers were instructed notify their customers of the recall and the actions required. Customers were asked to complete and return the enclosed business replay card even if they have no affected product in their inventory. Customers should complete the return goods packing slip, enclose it with their return goods shipment and affix the return label to the package. Customers with questions should call Customers Service at 1-800-743-4014. For questions regarding this recall call 919-269-1194.

Device

Biotene Moisturizing Mouth Spray
  • Modelo / Serial
    UPC: 048582001558, Lot numbers U3E031, U3E151, U3E211, U3F201, U3G031, U3G171, U3G231 and U3G311.
  • Clasificación del producto
    Dental Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution .
  • Descripción del producto
    Biotene Moisturizing Mouth Spray, with xylitol, For dry mouth symptom relief, 44.3ml/1.5 FL. OZ., Sugar Free Sweetened with xylitol and sorbitol, GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108. || Biotene Mouth Spray is used for the treatment of dry mouth
  • Manufacturer
    GlaxoSmithKline, LLC.

Manufacturer

GlaxoSmithKline, LLC.
  • Dirección del fabricante
    GlaxoSmithKline, LLC., 1011 North Arendell Ave, Zebulon NC 27597-1217
  • Empresa matriz del fabricante (2017)
    Glaxosmithkline Plc
  • Source
    USFDA