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October 24, 2000

Dentsply Preventive Care Recalls Illumine

York, PA (SafetyAlerts) - The Food and Drug Administration (FDA) said today that Dentsply Preventive Care is recalling certain lots of its IIllumine™ 30 Minute in-Office Tooth Whitener because of a defective coupling valve (stopcock) can result in the forceful ejection of the contents.

This is the first public notice of this Class II recall issued by FDA.

Illumine™ 30 Minute in-Office Tooth Whitener, 30% Hydrogen Peroxide.

Recall #D-002-1.

Catalog #614037P (20 pack) and 614037 (10 pack);
Lot Numbers: 1229, 1234, 1240, 1241, 1251, 1253, 1254, 1255, 1259, 1259A, 1262, and 1280.

Dentsply Preventive Care, York, Pennsylvania.

Manufacturer, by telephone on September 18, 2000. Firm-initiated recall ongoing.

Nationwide, Mexico, Germany, Argentina, Brazil, Australia, Japan, Hong Kong.

100,408 syringes (1,210 20-packs and 180 10-packs) were distributed.

Questions concerning this recall may be directed to the FDA at 1-888-INFO-FDA.

Selected Recent Recalls

Health Professional:

Did you know?
During 2000 there were over
1050 products recalled in the United
States for safety reasons!

How many did you hear about?

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