Recall Z-1675-2013— Angiodynamics, INC

Name: FDA recall Z-1675-2013
Creator: U.S. Food and Drug Administration
Published: 2013-06-11

Class II · Terminated

Class II FDA medical device recall by Angiodynamics, INC, initiated 2013-06-11, terminated 2015-06-12. It names one FDA 510(k) clearance: K040989. 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.. Reason: The RITA Main Cable product contains the incorrect Instructions for Use..

Recalling firm: Angiodynamics, INC
Classification: Class II
Status: Terminated
Initiated: 2013-06-11
Terminated: 2015-06-12
Firm location: Manchester, GA, United States

510(k) clearances named in this recall

1 on FDA's record

K040989 — RITA SYSTEMSRita Medical Systems·cleared 2004-04-28

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.