Device 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.
Z-0499-2013
Product summary
- Event
- Event 61209
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3594 pouches
- Official record key
device-enforcement:Z-0499-2013
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 202404, 202506, 203431,
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.