FDAFDA · Food and drugs·Recall number Z-0500-2013
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.
Published December 19, 2012 · Recall initiated: February 9, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Covidien LLC dba Uni-Patch
- Distributor
- Nationwide Distribution including CA, IL, MA, MN, and SD.
- Lot
- Lot 202406
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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