Recall Z-0498-2013— Covidien LLC dba Uni-Patch
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: K901575. Product: Reusable, non-sterile, self-adhering electrodes for use with TENS/NMES, . Made in the U.S.A. Cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the 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 recordK-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
Reusable, non-sterile, self-adhering electrodes for use with TENS/NMES, . Made in the U.S.A. Cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the 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.