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Covidien LLC dba Uni-Patch recalls Performa reusable and self-adhering TENS/NMES/FES stimulating electrodes, A cutaneous electrode is an electrode that
Recalled December 19, 2012 · FDA recall Z-0500-2013 · Covidien LLC
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. · FDA Class II
Units
3290
Sold at
Nationwide Distribution including CA, IL, MA, MN, and SD.
Description
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.
Product
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.
Manufacturer(s)
Covidien LLC dba Uni-Patch
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →