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U.S. Department of Health and Human Services

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 E-Mail
Distribution Pattern Nationwide Distribution including CA, IL, MA, MN, and SD.
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