FDAFDA · Food and drugs·Recall number Z-0499-2013
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.
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
- Lots 202404, 202506, 203431,
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.