FDA-Device2012-12-19Class II
Performa reusable and self-adhering TENS/NMES/FES stimulating electrodes, A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., electroencephalogram) or to apply electrical stimulation.
Covidien LLC dba Uni-Patch
Hazard
Covidien is conducting a voluntary recall regarding specific lots of TENS electrodes because it was determined that during the manufacturing process the surface of the wires in these lots may have been exposed to an employee who had a minor cut.
Sold states
Nationwide Distribution including CA, IL, MA, MN, and SD.
Affected count
3290
Manufactured in
1313 Grant Blvd W, N/A, Wabasha, MN, United States
Products
Performa reusable and self-adhering TENS/NMES/FES stimulating electrodes, A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., electroencephalogram) or to apply electrical stimulation.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0500-2013Don't want to check this manually?
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