Device 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.
Z-0498-2013
Product summary
- Event
- Event 61209
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2,014 pouches
- Official record key
device-enforcement:Z-0498-2013
Official wording
Reason: 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.
Code information: Lots 202028 and 202722
Distribution pattern: Nationwide Distribution including CA, IL, MA, MN, and SD.
Derived failure modes
-
Unknown
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.