Events

Retiro De Equipo (Recall) de Device Recall KaVo QUATTROcare Spray

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Kavo America Corporation.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    36896
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0289-2007
  • Fecha de inicio del evento
    2006-11-22
  • Fecha de publicación del evento
    2006-12-19
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-03-24
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49536
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    lubricant - Product Code EFB
  • Causa
    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.
  • Acción
    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
  • Modelo / Serial
    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.
  • Clasificación del producto
    Dental Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide and Canada
  • Descripción del producto
    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
  • Dirección del fabricante
    Kavo America Corporation, 340 E Main St, Lake Zurich IL 60047-2580
  • Source
    USFDA