Recall Z-0817-2013— NAImco Inc dba Richmar Inc

Name: FDA recall Z-0817-2013
Creator: U.S. Food and Drug Administration
Published: 2009-11-30

Class II · Terminated

Class II FDA medical device recall by NAImco Inc dba Richmar Inc, initiated 2009-11-30, terminated 2013-09-03. It names one FDA 510(k) clearance: K050469. Product: Foam Electrodes with Carbon construction: P/N 201-1261, Cat Nos.: 201-126, 203-678, and 400-856, 1.5&quot; x 3.5&quot; Electrode, Foam, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 201-1271, Cat Nos.: 201-127, 202-093, 203-483, 203-565, 203-673, and 400-873, 2&quot; x 2&quot; Electrode, Foam, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 201-1281, Cat Nos.: 201-128, 202-277, 203-675, and 400-873, 2&quot; Round Electrode, Foam, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 201-1291, Cat Nos.: 201-129, 203-677, and 400-882, 3&quot; Round Electrode, Foam, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 201-1301, Cat Nos.: 201-130, 203-679, and 400-855, 1.5&quot; x 3.5&quot; Electrode, Foam, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 201-1371, Cat Nos.: 201-137, 202-278, 203-484, 203-681, and 400-880, 2&quot; x 3.5&quot; Electrode, Foam, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 202-5671, Cat No. 202-567, 2&quot; x 2&quot; Electrode, Foam, All Serial Numbers distributed between 11/01/2009 and 01/31/2010. Cutaneous electrode.. Reason: Electrode Socket Terminal pulling away from the electrode lead wire when the electrical stim lead wire was removed..

Recalling firm: NAImco Inc dba Richmar Inc
Classification: Class II
Status: Terminated
Initiated: 2009-11-30
Terminated: 2013-09-03
Firm location: Chattanooga, TN, United States

510(k) clearances named in this recall

1 on FDA's record

K050469 — EZ-STIK ELECTRODESNaimco, Inc.·cleared 2005-05-13

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

Foam Electrodes with Carbon construction: P/N 201-1261, Cat Nos.: 201-126, 203-678, and 400-856, 1.5&quot; x 3.5&quot; Electrode, Foam, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 201-1271, Cat Nos.: 201-127, 202-093, 203-483, 203-565, 203-673, and 400-873, 2&quot; x 2&quot; Electrode, Foam, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 201-1281, Cat Nos.: 201-128, 202-277, 203-675, and 400-873, 2&quot; Round Electrode, Foam, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 201-1291, Cat Nos.: 201-129, 203-677, and 400-882, 3&quot; Round Electrode, Foam, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 201-1301, Cat Nos.: 201-130, 203-679, and 400-855, 1.5&quot; x 3.5&quot; Electrode, Foam, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 201-1371, Cat Nos.: 201-137, 202-278, 203-484, 203-681, and 400-880, 2&quot; x 3.5&quot; Electrode, Foam, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 202-5671, Cat No. 202-567, 2&quot; x 2&quot; Electrode, Foam, All Serial Numbers distributed between 11/01/2009 and 01/31/2010. Cutaneous electrode.

Reason for recall

Electrode Socket Terminal pulling away from the electrode lead wire when the electrical stim lead wire was removed.

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