Recall Z-0498-2013 ยท GXY Electrode, Cutaneous
Covidien LLC dba Uni-Patch
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.
| Date | Dec 10, 2012 (initiated Feb 9, 2012) |
| Status | Terminated |
| 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. |
| Root cause | Employee error |
| Action | Covidien sent An Urgent Product Recall letter, dated February 9, 2012, to all affected consignees. The letter identified the affected product, the problem, and the action to be taken by the customer. Customers were instructed to examine their inventory and quarantine the affected product if found. The letter asked customers to fill in teh quantity remaining in their inventory and fax it to 651-565-5888. A Covidien Customer Service rep would contact the consignee for returning product. Consignees were also requested to notify their customers of the recall. For questions regarding this re |
| Quantity | 2,014 pouches |
| Distribution | Nationwide Distribution including CA, IL, MA, MN, and SD. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K901575 | REUSABLE TENS PARAVERTEBRAL PAD #641 BACK ELECTROD Pioneering Technologies, Inc., May 2, 1990 |