Enforcement Report - Week of December 19, 2012
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Product Detail
| Product Description | 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. |
|---|---|
| Recall Number | Z-0501-2013 |
| Classification | Class II |
| Code Info | Lots 200300 and 201203 |
| Product Distributed Qty | 28,138 pouches |
| 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. |
Event Detail
| Event Id | 61209 |
|---|---|
| Product Type | Devices |
| Status | Completed |
| Recalling Firm | Covidien LLC dba Uni-Patch |
| City | Wabasha |
| State | MN | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-02-09 |
| Initial Firm Notification of Consignee or Public | |
| Distribution Pattern | Nationwide Distribution including CA, IL, MA, MN, and SD. |
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