Device Recall MACROLYTE

Beginning Lot Code 1204275; Ending Lot Code 1401075 (Lot code indicates the date of manufacture = yymmdds, where s is the shift).

General and Plastic Surgery Devices

2

No

Worldwide Distribution - USA (nationwide) and the countries of Australia, Belgium, Brazil, Canada, Ecuador, El Salvador, Finland, France, Great Britain, Honduras, India, Indonesia, Israel, Italy, Japan, Latvia, Lebanon, Malaysia, Mexico, Panama, Philippines, Portugal, Saudi Arabia, South Africa, Spain, Thailand, Trinidad, United Arab Emirates and Uruguay.

MACROLYTE Premie Dispersive Electrode, REF 440-2400, CONMED CORPORATION. The device is applied to the patient during electrosurgical procedures to provide a path for RF current to leave the patient and return to the generator.