FDA Device

RITA Starburst XL (3-5 cm Diameter/25cm Length), Electro-surgical Device, Manufactured by: RITA Medical Systems, Inc., One Horizon Way, Manchester, GA 31816

Hazard

The product may have a cracked tray which can compromise the sterility of the product.

What You Should Do

Remedy

Notification by letter of the AngioDynamics, Inc. sales force and the domestic and international distributors began on April 2, 2007. They were asked to return all affected devices to the Manchester, GA division of AngioDynamics, Inc. A reply form was attached to be completed and returned via fax to AngioDynamics.

Products

RITA Starburst XL (3-5 cm Diameter/25cm Length), Electro-surgical Device, Manufactured by: RITA Medical Systems, Inc., One Horizon Way, Manchester, GA 31816
Brand
Rita Medical Systems, Inc.
UPC
Part number: 700-101317, Lot number: 22330, 22793, 23297, 23306, 24413, 24655, 25120, 25355, 25425, 25545, 25546, 25547, 25632, 25747, 25748, 25806, 25807, 25808, 25850, 25851, 25876, 25940, 25941, 25971, 25979, 25980, 25981, 26145, 26146, 26456, 26457, 26458, 26496, 26555, 26556, 26581, 26663, 26664, 26930, 26931, 26986, 26987, 27068, 27158, 27168, 27326, 27401, 27437, 27554, 27555, 27711, 27818, 27874, 28189, 28200, 28314, 28462, 28471, 28474, 28556, 28557, 28578, 28635, 28636, 28637, 28709, 28902, 28903, 28965, 28967, 28979, 29041, 29052, 29153, 29250, 29277, 29278, 29426, 29542, 29543, 29670, 29775, 29793 and 29794 Part number 700-101317J (Japanese distribution), Lot numbers 26714, 26715, 27327, 27328, 27329, 27526, 27626, 27969, 28084, 28190, and 28250.

Units Affected

2331 devices