Recall Z-0499-2013 ยท GXY Electrode, Cutaneous
Covidien LLC dba Uni-Patch
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.
| 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 | 3594 pouches |
| Distribution | Nationwide Distribution including CA, IL, MA, MN, and SD. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K900519 | CLASSIC ECG/STIMULATING NO. 1700 SERIES Classic Medical Products, Inc., Mar 19, 1990 |