Z-0498-2013 Class II Terminated
FDA device recall Z-0498-2013 was initiated by Covidien LLC dba Uni-Patch on February 9, 2012 and is designated Class II. 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 bee… The recall status is terminated (terminated January 3, 2013). Affected quantity: 2,014 pouches.
Recall Details
- Product Type
- Devices
- Report Date
- December 19, 2012
- Initiation Date
- February 9, 2012
- Termination Date
- January 3, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,014 pouches
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.
Distribution Pattern
Nationwide Distribution including CA, IL, MA, MN, and SD.
Code Information
Lots 202028 and 202722