Recall Z-0816-2013 ยท GXY Electrode, Cutaneous
NAImco Inc dba Richmar Inc
Cloth electrodes with Silver-Carbon construction: P/N 202-9231, Cat No. 400-899, 2" x 2" Electrode, Cloth, AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 202-9241, Cat No. 400-895, 2" Round Electrode, Cloth, AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 202-9381, Cat No. 400-889, 2" x 3.5" Electrode, Cloth AG, All Serial
| 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 | 25860 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 |