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TO: DMR Regional Directors, STS Director, CTH Coordinators, Private Providers
FROM: Daniel A. Micari, Director of Quality Assurance, Division of Quality Management
DATE: November 1, 2004
RE: FDA MedWatch - Recall of Oral-B CrossAction Power and PowerMAX toothbrushes and refills

Please share this communication widely.

SAFETY ALERT

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Gillette and FDA notified healthcare professionals and consumers of a recall of Oral-B CrossAction Power and PowerMAX toothbrushes and refills. Instances have occurred where the brush head became loose in the mouth during the assisted brushing of teeth of persons with special needs, such as cerebral palsy or autism. During brushing, the loose brush head was caught in the throat or swallowed. Gillette recommended that consumers stop using these products to assist in brushing the teeth of people with special needs.

Read the MedWatch 2004 safety summary, including a link to the FDA recall notice, at:

http://www.fda.gov/medwatch/SAFETY/2004/safety04.htm#oralb