AngioDynamics RITA Main Cable, 9 Pin to 14 Pin, REF 700-101892. RITA Main Cables are indicated for use with the RITA RF
FDA device recall Z-1675-2013 · posted 2013-07-10 · Terminated
Recall details
- Recalling firm
- Angiodynamics, INC
- Reason for recall
- The RITA Main Cable product contains the incorrect Instructions for Use.
- 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.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- GEI
- Quantity affected
- 13 units
- Distribution
- Worldwide Distribution, including the US, Austria, China, Italy, Russia and the UK.
- Date initiated
- 2013-06-11
- Date posted
- 2013-07-10
- Date terminated
- 2015-06-12
- Location
- Manchester, GA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| RITA SYSTEMS (K040989) | Rita Medical Systems | 2004-04-28 |