Device 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.
Z-0500-2013
Product summary
- Event
- Event 61209
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3290
- Official record key
device-enforcement:Z-0500-2013
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: Lot 202406
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.