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U.S. Department of Health and Human Services

Class 2 Device Recall StarBurst

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  Class 2 Device Recall StarBurst see related information
Date Initiated by Firm May 02, 2006
Date Posted May 31, 2006
Recall Status1 Terminated 3 on February 05, 2008
Recall Number Z-0887-06
Recall Event ID 35342
510(K)Number K010060  
Product Classification Electrosurgical - Product Code GEI
Product 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
Code Information Catalog number: 700-102846 , Lot number 25969
Recalling Firm/
Manufacturer		 Rita Medical Systems, Inc.
1 Horizon Way
Manchester GA 31816-1749
For Additional Information Contact Karen Alexander
706-846-3216
Manufacturer Reason
for Recall		 Misbranding; Product may have the wrong device handle which incorrectly identifies the product and also has incorrect deployment depth marker.
FDA Determined
Cause 2		 Other
Action 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.
Quantity in Commerce 21 units
Distribution AL, AR, FL, LA, MA, NJ, NY, PA, TN, TX, UT and Italy
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = GEI and Original Applicant = RITA MEDICAL SYSTEMS
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