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U.S. Department of Health and Human Services

Class 2 Device Recall Cloth electrodes with Carbon construction

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  Class 2 Device Recall Cloth electrodes with Carbon construction see related information
Date Initiated by Firm November 30, 2009
Date Posted February 14, 2013
Recall Status1 Terminated 3 on September 03, 2013
Recall Number Z-0815-2013
Recall Event ID 63927
510(K)Number K050469  
Product Classification Electrode, cutaneous - Product Code GXY
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.
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 TN 37406-1021
For Additional Information Contact Chad Morgan
423-648-7730 Ext. 203
Manufacturer Reason
for Recall		 Electrode Socket Terminal pulling away from the electrode lead wire when the electrical stim lead wire was removed.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = GXY and Original Applicant = NAIMCO, INC.
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