Events

Rappel de Device Recall KaVo QUATTROcare Spray

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 Kavo America Corporation.

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
    36896
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0289-2007
  • Date de mise en oeuvre de l'événement
    2006-11-22
  • Date de publication de l'événement
    2006-12-19
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2008-03-24
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49536
  • 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
    lubricant - Product Code EFB
  • Cause
    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.
  • Action
    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
  • Modèle / numéro de série
    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.
  • Classification du dispositif
    Dental Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide and Canada
  • Description du dispositif
    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
  • Adresse du fabricant
    Kavo America Corporation, 340 E Main St, Lake Zurich IL 60047-2580
  • Source
    USFDA