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