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Covidien LLC dba Uni-Patch recalls Reusable, Self-Adhering TENS/NMES/FES electrodes Single Patient Use Only. An electrocardiograph electrode is the ele
Recalled December 19, 2012 · FDA recall Z-0499-2013 · 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
3594 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, Self-Adhering TENS/NMES/FES electrodes Single Patient Use Only. An electrocardiograph electrode is the electrical conductor which is applied to the surface of the body to transmit the electrical signal at the body surface to a processor that produces an electrocardiogram or vectorcardiogram.
Manufacturer(s)
Covidien LLC dba Uni-Patch
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →