This news item came accross my newswire accunt the other day. First I had heard about it. Anyone know whats going on?
The FDA Enforcement Report is published weekly by the Food and Drug Administration, Department of Health and Human Services. It contains information on actions taken in connection with agency Regulatory activities.
PRODUCT
Waterlase MD, dental laser unit, Model #6200218. Recall # Z-0543-05.
CODE
Serial Numbers: 10500210 to 10502680,inclusive.
RECALLING FIRM/MANUFACTURER
Biolase Technology, Inc., San Clemente, CA, by firm representative visit, on January 17, 2005. Firm initiated recall is ongoing.
REASON
Reports that the Waterlase MD, a dental laser unit, water bottle broke under pressure during installation.
VOLUME OF PRODUCT IN COMMERCE
209 units.
DISTRIBUTION
Nationwide and Internationally.