| | Class 2 Recall Foam Electrodes with Carbon construction |  |
| Date Posted |
February 14, 2013 |
| Recall Number |
Z-0817-2013 |
| Product |
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 Nos.: 201-128, 202-277, 203-675, and 400-873, 2" 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" 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" x 3.5" 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" x 3.5" Electrode, Foam, All Serial Numbers distributed between 11/01/2009 and 01/31/2010
P/N 202-5671, Cat No. 202-567, 2" x 2" Electrode, Foam, All Serial Numbers distributed between 11/01/2009 and 01/31/2010.
Cutaneous electrode. |
| Code Information |
All Serial Numbers distributed between 11/01/2009 and 01/31/2010
|
Recalling Firm/ Manufacturer |
NAImco Inc dba Richmar Inc 4120 S Creek Rd Chattanooga, Tennessee 37406-1021 |
| For Additional Information Contact |
Chad Morgan 423-648-7730 Ext. 203
|
Reason for Recall |
Electrode Socket Terminal pulling away from the electrode lead wire when the electrical stim lead wire was removed.
|
| 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 in Commerce |
129400 electrodes |
| Distribution |
Distributed in the states of GA and TN. |
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