Events

Retiro De Equipo (Recall) de Device Recall Benco Dental Tartar &38; Stain Remover

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 Heraeus Kulzer, 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
    67475
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1133-2014
  • Fecha de inicio del evento
    2014-02-10
  • Fecha de publicación del evento
    2014-03-04
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-06-18
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125522
  • 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
    Solution, cement disolving - Product Code KZP
  • Causa
    As the result of a complaint to heraeus kulzer's customer service department, heraues kulzer is recalling benco tartar and stain solution part #1010-451, lot #13121434 because it has incorrect labeling on the immediate container. while the outer carton correctly states "benco tartar and stain", the immediate gallon container in which the solution is contained incorrectly states "benco temporary c.
  • Acción
    Heraeus Kulzer, notified their one consignee of the recall February 4, 2014 via phone and then by official electronic notification. On February 7, 2014, an Important Communication Product Recall letter was also mailed to Benco direct accounts. On 2/10/14, Heraeus Kulzer also called Benco customers notifying them of the recall. The notifications explained the issue, identified the affected product and actions to be taken. For questions call 574-293-5444

Device

Device Recall Benco Dental Tartar &38; Stain Remover
  • Modelo / Serial
    Part #1010-451 Lot #13121434
  • Clasificación del producto
    Dental Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    USA Nationwide Distribution in the states AL, AR, AZ, CA, CO, FL, GA, IL, IN, KS, KY, LA, MI, MN, MO, MS, NC, ND, NE, NM, NV, OH, OK, PA, SC, TN, TX, UT, VA, WA, WI, WV
  • Descripción del producto
    BencoDental tartar & stain remover ultrasonic cleaning solution || Product Usage: Formulated especially for removal of calculus, tartar, tobacco and food stains from dentures, bridges, orthodontic appliances, etc. Use also for removal of permanent cement.
  • Manufacturer
    Heraeus Kulzer, LLC.

Manufacturer

Heraeus Kulzer, LLC.
  • Dirección del fabricante
    Heraeus Kulzer, LLC., 300 Heraeus Dr, South Bend IN 46614-2557
  • Empresa matriz del fabricante (2017)
    Mitsui Chemicals Inc.
  • Source
    USFDA