Z-0816-2013 Class II Terminated
FDA device recall Z-0816-2013 was initiated by NAImco Inc dba Richmar Inc on November 30, 2009 and is designated Class II. Reason for recall: Electrode Socket Terminal pulling away from the electrode lead wire when the electrical stim lead wire was removed. The recall status is terminated (terminated September 3, 2013). Affected quantity: 25860 electrodes.
Recall Details
- Product Type
- Devices
- Report Date
- February 20, 2013
- Initiation Date
- November 30, 2009
- Termination Date
- September 3, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 25860 electrodes
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.
Distribution Pattern
Distributed in the states of GA and TN.
Code Information
All Serial Numbers distributed between 11/01/2009 and 01/31/2010