Home / Recalls / NAImco Inc dba Richmar Inc / Z-0815-2013

Z-0815-2013 Class II Terminated

Recalled by NAImco Inc dba Richmar Inc — Chattanooga, TN

FDA device recall Z-0815-2013 was initiated by NAImco Inc dba Richmar Inc on November 30, 2009 and is designated Class II. Reason for recall: Electrode Socket Terminal pulling away from the electrode lead wire when the electrical stim lead wire was removed. The recall status is terminated (terminated September 3, 2013). Affected quantity: 209860 electrodes.

Recall Details

Product Type
Devices
Report Date
February 20, 2013
Initiation Date
November 30, 2009
Termination Date
September 3, 2013
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
209860 electrodes

Product Description

Cloth electrodes with Carbon construction: P/N 201-1231, Cat Nos.: 201-123, 202-454, 203-118, 203-342, 203-454, 203-493, 203-672, 400-877, and 400-877-BJC, 2" x 2" Electrode, Cloth, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 201-1241, Cat Nos.: 201-124, 202-455, 203-340, 203-674, and 400-872, 2" Round Electrode, Cloth, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 201-1251, Cat Nos.: 201-138, 202-276, 202-456, 203-336, 203-680, and 400-879, 3" Round Electrode, Cloth, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 201-1381, Cat Nos.: 201-126, 203-678, and 400-856, 2" x 3.5" Electrode, Cloth, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 201-1501, Cat Nos.: 201-150 and 400-863, 1.25" Round Electrode, Cloth, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 201-1521, Cat No. 400-852, 3 x 5 Electrode, Cloth, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 201-1541, Cat Nos.:201-154 and 400-865 1.5 x 2.5 Oval Electrode, Cloth, 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.

Distribution Pattern

Distributed in the states of GA and TN.

Code Information

All Serial Numbers distributed between 11/01/2009 and 01/31/2010

Other recalls by NAImco Inc dba Richmar Inc

  • Z-0816-2013 Class II — Cloth electrodes with Silver-Carbon construction: P/N 202-9231, Cat No. 400-899 (November 30, 2009)
  • Z-0818-2013 Class II — Foam electrodes with Silver-Carbon construction: P/N 202-9271, Cat No. 400-898, (November 30, 2009)
  • Z-0817-2013 Class II — Foam Electrodes with Carbon construction: P/N 201-1261, Cat Nos.: 201-126, 203- (November 30, 2009)

FDA data resources