KaVo QUATTROcare Spray, 500 ml aerosol can; a maintenance spray for lubrication of KaVo turbines, air motors, straight a

FDA device recall Z-0289-2007 · posted 2006-12-19 · Terminated

Recall details

Recalling firm

Kavo America Corporation

Reason for recall

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 taken

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.

Root cause

Other

Status

Terminated

Product code

EFB

Quantity affected

619,434 cans plus 23,088 replacement cans

Distribution

Nationwide and Canada

Date initiated

2006-11-22

Date posted

2006-12-19

Date terminated

2008-03-24

Location

Lake Zurich, IL

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