Cloth electrodes with Silver-Carbon construction: P/N 202-9231, Cat No. 400-899, 2" x 2...
FDA Recall #Z-0816-2013 — Class II — November 30, 2009
Product Description
Cloth electrodes with Silver-Carbon construction: P/N 202-9231, Cat No. 400-899, 2" x 2" Electrode, Cloth, AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 202-9241, Cat No. 400-895, 2" Round Electrode, Cloth, AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 202-9381, Cat No. 400-889, 2" x 3.5" Electrode, Cloth AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 202-9501, Cat No. 202-9501, 1.25" Round Electrode, Cloth AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 400-8991, Cat Nos.: 400-877T and 400-899T, 2" x 2.25" Electrode, Cloth, AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010. Cutaneous electrode.
Reason for Recall
Electrode Socket Terminal pulling away from the electrode lead wire when the electrical stim lead wire was removed.
Recalling Firm
NAImco Inc dba Richmar Inc — Chattanooga, TN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
25860 electrodes
Distribution
Distributed in the states of GA and TN.
Code Information
All Serial Numbers distributed between 11/01/2009 and 01/31/2010
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated