Device Recall Arm and Hammer 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Church & Dwight Inc 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    60853
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2094-2012
  • 사례 시작날짜
    2011-12-22
  • 사례 출판 날짜
    2012-01-25
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2015-04-14
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 비고 / 경고
    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.
  • 데이터 추가 비고
    Toothbrush, powered - Product Code JEQ
  • 원인
    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.
  • 조치
    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

  • 모델명 / 제조번호(시리얼번호)
    Arm and Hammer Spinbrush Pro Clean Sonic Color Wear Powered Toothbrush (668780016202)
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution.
  • 제품 설명
    Arm and Hammer Spinbrush Pro Clean Sonic Color Wear Powered Toothbrush Made in China. || Manufactured for Church and Dwight Co., Inc. Princeton, NJ 08543 USA. || For dental health; plaque removal
  • Manufacturer

Manufacturer

  • 제조사 주소
    Church & Dwight Inc, 469 N Harrison St, Princeton NJ 08540-3510
  • 제조사 모회사 (2017)
  • Source
    USFDA