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U.S. Department of Health and Human Services

Class 2 Device Recall RITA Main Cable

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 Class 2 Recall
RITA Main Cable
see related information
Date Posted July 10, 2013
Recall Status1 Open
Recall Number Z-1675-2013
Recall Event ID 65439
Premarket Notification
510(K) Number
K040989 
Product Classification Electrosurgical, Cutting & Coagulation & Accessories - Product Code GEI
Product AngioDynamics RITA Main Cable, 9 Pin to 14 Pin, REF 700-101892. RITA Main Cables are indicated for use with the RITA RF Generators and RITA electrosurgical devices.
Code Information Catalog #700-101892, Lot number: 30.12
Recalling Firm/
Manufacturer
Angiodynamics, INC
1 Horizon Way
Manchester, Georgia 31816-1749
For Additional Information Contact Mark Frost
518-795-1981
Manufacturer Reason
for Recall
The RITA Main Cable product contains the incorrect Instructions for Use.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Packaging Process Control
Action Consignees were notified via certified mail on 06/11/2013 with an "Urgent Medical Device Field Safety Correction" notification. This included the correct Instructions for Use and the recommended actions.
Quantity in Commerce 13 units
Distribution Worldwide Distribution, including the US, Austria, China, Italy, Russia and the UK.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = GEI and Original Applicant = RITA MEDICAL SYSTEMS
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