Retiro De Equipo (Recall) de Device Recall Arm and Hammer

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 Church & Dwight 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
    60853
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2093-2012
  • Fecha de inicio del evento
    2011-12-22
  • Fecha de publicación del evento
    2012-01-25
  • Estado del evento
    Terminated
  • País del evento
  • Fecha de finalización del evento
    2015-04-14
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
  • 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
    Toothbrush, powered - Product Code JEQ
  • Causa
    Church and dwight plans to take actions to best convey to the public the potential small parts choking hazard with using a spinbrush beyond the recommended 3-month brush head life.
  • Acción
    Church & Dwight Co., Inc. proposed a consumer education media campaign starting on December 22, 2011 with the following statement: "Safety Notice: Please remember to replace your brush head after 3 months of use, or if the brush is damaged or the parts become loose. Extended usage, loose parts or excessive wear could lead to brush head breakage, generation of small parts and possible choking hazard. Inspect the brush for loose parts before use." The campaign will be conducted in the following media and anticipate that the combined consumer reach of all of these vehicles to be approximately 144 million people an average of 4 times. - Television campaign will be run during the entire Q1 of 2012 (January -March). -Print ads that will appear in the December 30th issues of People, Star, US Weekly and Entertainment Weekly. -Church & Dwight Website will contain the Safety Alert notice starting December 22nd. (www.spinbrush.com) Consumer Relations IVR (Interactive Voice Response) to consumers calling the Spinbrush toll-free numbers). (800-353-3384 and 800-5610752). 4-30-12 1) A print advertisement (Attachment A) containing the Sonic Safety Notice that will appear in each magazine (Star, People, US Weekly, and Entertainment Weekly) as noted: Five total print insertions are planned (on sale dates listed): I. 4/30 -Star 2. 5/14 -Us Weekly 3. 5/28 -People 4. 6/11 -Entertainment Weekly 5. 6/25 -Star 2) A disk containing the 15 second commercial containing the safety notice. 3) A document (Attachment B) of the National TV slots showing when the commercials will run in the quarter, and another with the shows during which they will air. TV ads will begin running the week of April 16th. The DRTV schedule is determined weekly and we are informed after the fact when the ads where shown. The DRTV stations are included at the bottom of the National TV listing. " In total, combined print and TV are estimated to reach 163MM impressions (measurement target: women

Device

  • Modelo / Serial
    Arm and Hammer Spinbrush Pro Clean Sonic Powered Toothbrush (668780016201)
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution.
  • Descripción del producto
    Arm and Hammer Spinbrush Pro Clean Sonic Powered Toothbrush Made in China. || Manufactured for Church and Dwight Co., Inc. Princeton, NJ 08543 USA. || For dental health; plaque removal.
  • Manufacturer

Manufacturer

  • Dirección del fabricante
    Church & Dwight Inc, 469 N Harrison St, Princeton NJ 08540-3510
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA