October 24, 2000Dentsply Preventive Care Recalls
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.
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.
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