Recall Z-0817-2013 ยท GXY Electrode, Cutaneous
NAImco Inc dba Richmar Inc
Foam Electrodes with Carbon construction: P/N 201-1261, Cat Nos.: 201-126, 203-678, and 400-856, 1.5" x 3.5" 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" x 2" Electrode, Foam, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 201-1281, Cat
| Date | Feb 14, 2013 (initiated Nov 30, 2009) |
| Status | Terminated |
| Reason | Electrode Socket Terminal pulling away from the electrode lead wire when the electrical stim lead wire was removed. |
| Root cause | Unknown/Undetermined by firm |
| Action | Rich-Mar sent "URGENT: MEDICAL DEVICE VOLUNTARY RECALL" letters to affected customers beginning on 11/30/2009. The letter identified the product, problem, and actions to be taken by the customers. Contact the firm at 423-648-7730 ext. 214 for questions relating to t his recall. |
| Quantity | 129400 electrodes |
| Distribution | Distributed in the states of GA and TN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050469 | EZ-STIK ELECTRODES Naimco, Inc., May 13, 2005 |