FDAFDA · Food and drugs·Recall number Z-0816-2013
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.
Published February 20, 2013 · Recall initiated: November 30, 2009
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Electrode Socket Terminal pulling away from the electrode lead wire when the electrical stim lead wire was removed.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- NAImco Inc dba Richmar Inc
- Distributor
- Distributed in the states of GA and TN.
- Lot
- All Serial Numbers distributed between 11/01/2009 and 01/31/2010
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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