FDA-Device2012-12-19Class II
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.
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
3594 pouches
Manufactured in
1313 Grant Blvd W, N/A, Wabasha, MN, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0499-2013Don't want to check this manually?
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