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U.S. Department of Health and Human Services

Class 2 Device Recall StarBurst

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 Class 2 Recall
StarBurst
see related information
Date Posted May 31, 2006
Recall Status1 Open
Recall Number Z-0887-06
Recall Event ID 35342
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, Georgia 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.
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

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
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