Events

Rappel de Device Recall Arm and Hammer

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Church & Dwight Inc.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    60853
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2099-2012
  • Date de mise en oeuvre de l'événement
    2011-12-22
  • Date de publication de l'événement
    2012-01-25
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-04-14
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108923
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Toothbrush, powered - Product Code JEQ
  • Cause
    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.
  • Action
    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

Device Recall Arm and Hammer
  • Modèle / numéro de série
    Arm and Hammer Spinbrush Pro Clean Sonic Recharge (668780094002)
  • Classification du dispositif
    Dental Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution.
  • Description du dispositif
    Arm and Hammer Spinbrush ProClean Sonic Recharge Color Wear Made in China. || Manufactured for Church and Dwight Co., Inc. Princeton, NJ 08543 USA. || For dental health; plaque removal.
  • Manufacturer
    Church & Dwight Inc

Manufacturer

Church & Dwight Inc
  • Adresse du fabricant
    Church & Dwight Inc, 469 N Harrison St, Princeton NJ 08540-3510
  • Société-mère du fabricant (2017)
    Church & Dwight Co., Inc.
  • Source
    USFDA