Rita Medical Systems

Lot numbers: Y072103-3, Y082003

General and Plastic Surgery Devices

2

No

Product was released for distribution to 66 consignees in US. The product received nationwide distribution. The recall was appropriately extended to the user level; i.e., the hospitals that received the recalled product. There were no shipments to foreign or Canadian distribution, however, it includes one military distribution: Wilford Hall Medical Center, 2200 Berquist Dr., 31, Lackland AFB, TX 78236.

RITA brand ThermoPad, Electrosurgical RF Generator and accessories || Part Number: 700-102649

Lot codes affected: Y110503-1 and Y103003-2. 510k number : k031926 Contract manufacturer, Katecho, Inc, registration number 1932007

General and Plastic Surgery Devices

2

No

Product was shipped to 18 field representatives and 87 customers (hospitals and medical centers

Dispersive Electrodes packaged in an 8x10 plastic container.