Recall Z-0500-2013— Covidien LLC dba Uni-Patch

Name: FDA recall Z-0500-2013
Creator: U.S. Food and Drug Administration
Published: 2012-02-09

Class II · Terminated

Class II FDA medical device recall by Covidien LLC dba Uni-Patch, initiated 2012-02-09, terminated 2013-01-03. It names one FDA 510(k) clearance: K915333. Product: Performa reusable and self-adhering TENS/NMES/FES stimulating electrodes, 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.. Reason: 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..

Recalling firm: Covidien LLC dba Uni-Patch
Classification: Class II
Status: Terminated
Initiated: 2012-02-09
Terminated: 2013-01-03
Firm location: Wabasha, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K915333 — ELECTRODE USING PROMEON RG-60 SERIES GELLabeltape Meditect, Inc.·cleared 1992-01-14

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Performa reusable and self-adhering TENS/NMES/FES stimulating electrodes, 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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.