Recalls / —
—#118894
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.
- FDA product code
- GEI — Electrosurgical, Cutting & Coagulation & Accessories
- Device class
- Class 2
- Medical specialty
- General, Plastic Surgery
- 510(k) numbers
- K040989
- Affected lot / code info
- Catalog #700-101892, Lot number: 30.12
Why it was recalled
The RITA Main Cable product contains the incorrect Instructions for Use.
Root cause (FDA determination)
Packaging process control
Action the firm took
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.
Recalling firm
- Firm
- Angiodynamics, INC
- Address
- 1 Horizon Way, Manchester, Georgia 31816-1749
Distribution
- Distribution pattern
- Worldwide Distribution, including the US, Austria, China, Italy, Russia and the UK.
Timeline
- Recall initiated
- 2013-06-11
- Posted by FDA
- 2013-07-10
- Terminated
- 2015-06-12
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #118894. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.