Home / Recalls / Covidien LLC dba Uni-Patch / Z-0498-2013

Z-0498-2013 Class II Terminated

Recalled by Covidien LLC dba Uni-Patch — Wabasha, MN

Recall Details

Product Type
Devices
Report Date
December 19, 2012
Initiation Date
February 9, 2012
Termination Date
January 3, 2013
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2,014 pouches

Product Description

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.

Reason for Recall

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.

Distribution Pattern

Nationwide Distribution including CA, IL, MA, MN, and SD.

Code Information

Lots 202028 and 202722

Other recalls by Covidien LLC dba Uni-Patch

  • Z-0500-2013 Class II — Performa reusable and self-adhering TENS/NMES/FES stimulating electrodes, A c (February 9, 2012)
  • Z-0501-2013 Class II — Empi STIMC RE Self Adhesive electrodes. For use on TENS, NMES, FES. a DJO bran (February 9, 2012)
  • Z-0499-2013 Class II — Reusable, Self-Adhering TENS/NMES/FES electrodes Single Patient Use Only. An (February 9, 2012)