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U.S. Department of Health and Human Services

Enforcement Report - Week of July 17, 2013

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Event Detail

Event ID 65439
Product Type Devices
Status Ongoing
Recalling Firm Angiodynamics, INC
City Manchester
State GA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-06-11
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Worldwide Distribution, including the US, Austria, China, Italy, Russia and the UK.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. Catalog #700-101892, Lot number: 30.12 Class II The RITA Main Cable product contains the incorrect Instructions for Use. 13 units Z-1675-2013
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