| | Class 2 Recall
Empi STIMC RE Self Adhesive electrodes |  |
| Date Posted |
December 10, 2012 |
| Recall Number |
Z-0501-2013 |
| Product |
Empi STIMC RE Self Adhesive electrodes. For use on TENS, NMES, FES. a DJO brand
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. |
| Code Information |
Lots 200300 and 201203
|
Recalling Firm/
Manufacturer |
Covidien LLC dba Uni-Patch
1313 Grant Blvd W
Wabasha, Minnesota 55981-1058 |
| Consumer Instructions |
Contact the recalling firm for information |
| For Additional Information Contact |
Customer Service
651-565-5728
|
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.
|
| 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 recall call 508-261-8532. |
| Quantity in Commerce |
28,138 pouches |
| Distribution |
Nationwide Distribution including CA, IL, MA, MN, and SD. |
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