FDA Device

Talon Straight, 25 cm--Electrosurgical Device--RITA * Medical Systems, Inc. * StarBurst Talon * * REF: 700-102846 * 4 cm Diameter * 25 cm Length * Sterile/R * Catalog # 700-102846-RITA * Manufactured by: Rita Medical Systems, Inc., One Horizon Way, Manchester, Georgia 31816, USA

Hazard

Misbranding; Product may have the wrong device handle which incorrectly identifies the product and also has incorrect deployment depth marker.

What You Should Do

Remedy

Consignees were first notified by telephone on 05/02/2006. A follow up letter was sent on 05/03/2006. The European Medical Device Agency, the Italian Competent Authority and British Standards Institution were notified by email on 05/03/2006.

Products

Talon Straight, 25 cm--Electrosurgical Device--RITA * Medical Systems, Inc. * StarBurst Talon * * REF: 700-102846 * 4 cm Diameter * 25 cm Length * Sterile/R * Catalog # 700-102846-RITA * Manufactured
Brand
Rita Medical Systems, Inc.
UPC
Catalog number: 700-102846 , Lot number 25969

Units Affected

21 units