Date Initiated by Firm |
June 11, 2013 |
Date Posted |
July 10, 2013 |
Recall Status1 |
Terminated 3 on June 12, 2015 |
Recall Number |
Z-1675-2013 |
Recall Event ID |
65439 |
510(K)Number |
K040989
|
Product Classification |
Electrosurgical, cutting & coagulation &accessories - Product Code GEI
|
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. |
Code Information |
Catalog #700-101892, Lot number: 30.12 |
Recalling Firm/ Manufacturer |
Angiodynamics, INC 1 Horizon Way Manchester GA 31816-1749
|
For Additional Information Contact |
Mark Frost 518-795-1981
|
Manufacturer Reason for Recall |
The RITA Main Cable product contains the incorrect Instructions for Use.
|
FDA Determined Cause 2 |
Packaging process control |
Action |
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. |
Quantity in Commerce |
13 units |
Distribution |
Worldwide Distribution, including the US, Austria, China, Italy, Russia and the UK. |
Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database |
510(K)s with Product Code = GEI and Original Applicant = RITA MEDICAL SYSTEMS
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