| Class 2 Device Recall Foam Electrodes with Carbon construction | |
Date Initiated by Firm | November 30, 2009 |
Date Posted | February 14, 2013 |
Recall Status1 |
Terminated 3 on September 03, 2013 |
Recall Number | Z-0817-2013 |
Recall Event ID |
63927 |
510(K)Number | K050469 |
Product Classification |
Electrode, cutaneous - Product Code GXY
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Product | Foam Electrodes with Carbon construction:
P/N 201-1261, Cat Nos.: 201-126, 203-678, and 400-856, 1.5" x 3.5" Electrode, Foam, All Serial Numbers distributed between 11/01/2009 and 01/31/2010
P/N 201-1271, Cat Nos.: 201-127, 202-093, 203-483, 203-565, 203-673, and 400-873, 2" x 2" Electrode, Foam, All Serial Numbers distributed between 11/01/2009 and 01/31/2010
P/N 201-1281, Cat Nos.: 201-128, 202-277, 203-675, and 400-873, 2" Round Electrode, Foam, All Serial Numbers distributed between 11/01/2009 and 01/31/2010
P/N 201-1291, Cat Nos.: 201-129, 203-677, and 400-882, 3" Round Electrode, Foam, All Serial Numbers distributed between 11/01/2009 and 01/31/2010
P/N 201-1301, Cat Nos.: 201-130, 203-679, and 400-855, 1.5" x 3.5" Electrode, Foam, All Serial Numbers distributed between 11/01/2009 and 01/31/2010
P/N 201-1371, Cat Nos.: 201-137, 202-278, 203-484, 203-681, and 400-880, 2" x 3.5" Electrode, Foam, All Serial Numbers distributed between 11/01/2009 and 01/31/2010
P/N 202-5671, Cat No. 202-567, 2" x 2" Electrode, Foam, 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 |
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 | 129400 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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