Enforcement Report - Week of December 19, 2012
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Product Detail
| Product Description | 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. |
|---|---|
| Recall Number | Z-0499-2013 |
| Classification | Class II |
| Code Info | Lots 202404, 202506, 203431, |
| Product Distributed Qty | 3594 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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