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Covidien LLC dba Uni-Patch recalls Reusable, non-sterile, self-adhering electrodes for use with TENS/NMES, . Made in the U.S.A. Cutaneous electrode is an
Recalled December 19, 2012 · FDA recall Z-0498-2013 · 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
2,014 pouches
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
Reusable, non-sterile, self-adhering electrodes for use with TENS/NMES, . Made in the U.S.A. Cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the 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 →