The Recall Desk
ModerateFDA (Devices)·Z-1675-2013·Announced 2013-07-17

AngioDynamics RITA Main Cable Recalled for Incorrect Instructions for Use

AngioDynamics is recalling 13 RITA Main Cables because they contain incorrect Instructions for Use. The cables are used with RITA RF Generators and electrosurgical devices.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard is a labeling error (incorrect Instructions for Use) without reported injuries or illnesses, fitting the criteria for a moderate severity score.

Plain-English summary

AngioDynamics, INC is recalling 13 units of the RITA Main Cable, 9 Pin to 14 Pin (REF 700-101892). The recall is due to the product containing incorrect Instructions for Use. These cables are indicated for use with RITA RF Generators and RITA electrosurgical devices.

The affected units were distributed worldwide, including in the US, Austria, China, Italy, Russia, and the UK. The specific lot number for the recalled items is 30.12.

Healthcare providers and consumers should stop using the affected cables and contact AngioDynamics for further instructions or a replacement.

The recalled product

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.
Manufacturer
Angiodynamics, INC
Affected units
13

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Catalog #700-101892
  • Lot number: 30.12

Distribution

Distribution scope not specified by the agency.