Z-0815-2013Class II

Cloth electrodes with Carbon construction: P/N 201-1231, Cat Nos.: 201-123, 202-454, 203-118, 203-342...

Name: Z-0815-2013 Cloth electrodes with Carbon construction: P/N 201-1231, Cat Nos.: 201-123, 202-454, 203-118, 203-342...
Creator: NAImco Inc dba Richmar Inc
Published: 2009-11-30
License: https://open.fda.gov/license/

NAImco Inc dba Richmar Inc / initiated 2009-11-30 / Terminated

FDA source

NAImco Inc dba Richmar Inc began a recall of 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"... on 2009-11-30. FDA classified it as Class II and gives the reason as "Electrode Socket Terminal pulling away from the electrode lead wire when the electrical stim lead wire was removed". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0815-2013
Classification: Class II
Status: Terminated
Initiated: 2009-11-30
Posted: 2013-02-14
Terminated: 2013-09-03
Recalling firm: NAImco Inc dba Richmar Inc
Product: 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.
Product code: GXY Electrode, Cutaneous
Reason for recall: Electrode Socket Terminal pulling away from the electrode lead wire when the electrical stim lead wire was removed.
FDA 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 in commerce: 209860 electrodes
Distribution: Distributed in the states of GA and TN.
Product codes and lots: All Serial Numbers distributed between 11/01/2009 and 01/31/2010

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0815-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0815-2013	Class II	Terminated	Voluntary: Firm initiated	2013-02-20	2013-02-14
Z-0816-2013	Class II	Terminated	Voluntary: Firm initiated	2013-02-20	2013-02-14
Z-0817-2013	Class II	Terminated	Voluntary: Firm initiated	2013-02-20	2013-02-14
Z-0818-2013	Class II	Terminated	Voluntary: Firm initiated	2013-02-20	2013-02-14

Product code GXY

K050469Class IIEz-Stik ElectrodesNaimco, Inc. / cleared 2005-05-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-06. View this recall on fda.gov (opens on fda.gov)