BEUDAMED
    FDA Recall Terminated

    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

    Recall: Z-0289-2007 · Initiated November 22, 2006

    Recall

    Recall Number
    Z-0289-2007
    Event Number
    36896
    Firm
    Kavo America Corporation
    FEI Number
    1419798
    Product Code
    EFB
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 22, 2006
    Posted
    December 19, 2006
    Terminated
    March 24, 2008
    Address
    340 E Main, St Lake Zurich, IL, 60047-2580

    Description

    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

    Reason

    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.

    Distribution

    Nationwide and Canada

    Quantity

    619,434 cans plus 23,088 replacement cans