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Class 2 Device Recall Cloth electrodes with Carbon construction |
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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
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Product Classification |
Electrode, cutaneous - Product Code GXY
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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
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For Additional Information Contact |
Chad Morgan 423-648-7730 Ext. 203
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Manufacturer Reason for Recall |
Electrode Socket Terminal pulling away from the electrode lead wire when the electrical stim lead wire was removed.
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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
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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.
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510(K) Database |
510(K)s with Product Code = GXY and Original Applicant = NAIMCO, INC.
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