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U.S. Department of Health and Human Services

Class 2 Device Recall Foam Electrodes with SilverCarbon construction

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 Class 2 Recall
Foam Electrodes with SilverCarbon construction
see related information
Date Posted February 14, 2013
Recall Status1 Terminated on September 03, 2013
Recall Number Z-0818-2013
Recall Event ID 63927
Premarket Notification
510(K) Number
K050469 
Product Classification Electrode, Cutaneous - Product Code GXY
Product Foam electrodes with Silver-Carbon construction: P/N 202-9271, Cat No. 400-898, 2" x 2" Electrode, Foam, AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 202-9281, Cat No. 202-9281, 2" Round Electrode, Foam, AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 202-9251, Cat No. 400-893, 3" Round Electrode, Foam AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 202-9291, Cat No. 400-892, 3" Round Electrode, Foam AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 202-9371, Cat No. 400-888, 2" x 3.5" Electrode, Foam AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 202-9491, Cat No. 400-869, 1.25" Round Electrode, Foam AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 202-9511, Cat No. 400-853, 3" x 5" Electrode, Foam AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 300-1541, Cat No. 300-154, 2" x 2.25" Electrode, Foam, AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 300-1561, Cat No. 300-156, 2" Round Electrode, Foam, AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 300-1611, Cat No. 300-161, 4" x 2.25" Electrode, Foam, AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010, 22818 P/N 300-1631, Cat No. 300-163, 3" Round Electrode, Foam, AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 400-8701, Cat No. 400-870, 2" x 4" Oval Electrode, Foam, AG, 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
Consumer Instructions Contact the recalling firm for information
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
DESIGN: Component Design/Selection
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 56980 electrodes
Distribution Distributed in the states of GA and TN.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = GXY and Original Applicant = NAIMCO, INC.
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