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.
This recall has been terminated (originally issued July 10, 2013).
- Company
- Angiodynamics, Inc
- Recall Initiated
- June 11, 2013
- Posted
- July 10, 2013
- Terminated
- June 12, 2015
- Recall Number
- Z-1675-2013
- Quantity
- 13 units
- Firm Location
- Manchester, GA
- Official Source
- View on FDA website ↗
Reason for Recall
The RITA Main Cable product contains the incorrect Instructions for Use.
Distribution
Worldwide Distribution, including the US, Austria, China, Italy, Russia and the UK.
Lot / Code Info
Catalog #700-101892, Lot number: 30.12
Root Cause
Packaging process control
Action Taken
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.
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