| Class 2 Device Recall Foam Electrodes with SilverCarbon construction | |
Date Initiated by Firm | November 30, 2009 |
Date Posted | February 14, 2013 |
Recall Status1 |
Terminated 3 on September 03, 2013 |
Recall Number | Z-0818-2013 |
Recall Event ID |
63927 |
510(K)Number | K050469 |
Product Classification |
Electrode, cutaneous - Product Code GXY
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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 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 | 56980 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
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