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AngioDynamics RITA Main Cable, 9 Pin to 14 Pin, REF… recallZ-1675-2013 · Angiodynamics, INC · initiated Jun 11, 2013

Class II Terminated All recalls posted in July 2013

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Angiodynamics, INC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

The RITA Main Cable product contains the incorrect Instructions for Use.

FDA root cause category: Packaging process control

What the company is doing

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.

Recall details

Recall number
Z-1675-2013
Recall class
Class II
Status
Terminated
Initiated by the company
Jun 11, 2013
Posted by the FDA
Jul 10, 2013
Recalling firm
Angiodynamics, INC
Quantity
13 units
Product code
GEI
FDA submissions
K040989
Distribution
Worldwide Distribution, including the US, Austria, China, Italy, Russia and the UK.

Product description

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 (models, lots, serial numbers)

Catalog #700-101892, Lot number: 30.12

Other devices under the same FDA submission

3 devices cleared under K040989 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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