FDA Device

ThermaCool TC 1.0 cm2 Treatment Tip, Single Patient Use Only

Hazard

Product tip has potential to liquid leakage into the internal circuitry causing malfunction and may result in epidermal injury.

What You Should Do

Remedy

The recall notification was faxed to all 54 consignees on 12/8/02. A follow-up hard copy of the recall notification was sent via FedEx on 12/9/02.

Products

ThermaCool TC 1.0 cm2 Treatment Tip, Single Patient Use Only
Brand
Thermage
UPC
M00023,  M00024,  M00029, M00031, M00033R, M00034, M00035,

Units Affected

1,326 units