Events

Device Recall KaVo QUATTROcare Spray 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Kavo America Corporation 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
    36896
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0289-2007
  • 사례 시작날짜
    2006-11-22
  • 사례 출판 날짜
    2006-12-19
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2008-03-24
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49536
  • 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
    lubricant - Product Code EFB
  • 원인
    The quattrocare spray cans may allow the gas (propane) to escape from the can under certain circumstances. in rare cases, when an ignition source is nearby, this escape of gas may lead to the emission of smoke and possibly flames from the can which could lead to property damage or personnel injury.
  • 조치
    KaVo notified their dealers by registered/certified mail, telephone calls and by email on 11/22/06. They also posted the recall message on the www.KAVOUSA.com website. The dealers were informed of the potential fire/explosion hazard of the cans, and requested them to segregate the cans from their inventory for return to KaVo for replacement. The dealers were requested to contact all of their customers who purchased a Quattrocare device or Quattrocare spray can within the last two years, advise them of the recall, and let them know that replacement cans will be provided at no charge. The dealers were requested to notify their customers by 11/29/06, and were provided with a letter to send to the dentists. Any questions were directed to KaVo customer service at 1-888-ASK-KAVO. ******* KaVo expanded the recall to include the replacement cans with lot numbers ending in R3X via letters dated 2/26/07. The instructions and recall strategy remain the same as in the 11/22/06 letter, but requesting the dealers to notify their customers by 2/28/07. The QUATTROcare Spray will be replaced with Kavo Spray until the problem with the QUATTROcare Spray is resolved.

Device

Device Recall KaVo QUATTROcare Spray
  • 모델명 / 제조번호(시리얼번호)
    All cans manufactured prior to 11/18/06  On 2/26/07 the firm expanded the recall to include the replacement product which has a lot code on the bottom of the can that ends in R3X.
  • 의료기기 분류등급
    Dental Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide and Canada
  • 제품 설명
    KaVo QUATTROcare Spray, 500 ml aerosol can; a maintenance spray for lubrication of KaVo turbines, air motors, straight and contra-angle dental handpieces. For use with the KaVo QUATTROcare maintenance unit only; Made in Germany || The spray was produced under the following labels: || a) KaVo QUATTROcare Spray AMERICA, Kaltenbach & Voigt GmbH, Biberach/Riss Germany, || single can: item #04117630, type 2106, || 6-pack: item #04117640, type 2106A || b) KaVo QUATTROcare Spray CANADA, Kaltenbach & Voigt GmbH, Biberach/Riss Germany; Distributed by SciCan, 1440 Don Mills Rd, Toronto, Ontario, Canada M3B 3P9, || single can: item #04117680, type 2107, || 6-pack: item #04117690, type 2107A || c) KaVo QUATTROcare Spray, Kaltenbach & Voigt GmbH, Postfach 1454, D-88396 Biberach/Riss Germany, || single can: item #04117590, type 2108, || 6-pack: item #04117720, type 2108A
  • Manufacturer
    Kavo America Corporation

Manufacturer

Kavo America Corporation
  • 제조사 주소
    Kavo America Corporation, 340 E Main St, Lake Zurich IL 60047-2580
  • Source
    USFDA