IontoPatch 80, On-the-Go Patch Therapy, Model/Catalog Number: D-0077-080; The IontoPatch is an Iontophoresis transdermal patch.

Reason: The nonwoven pads in the device do not absorb the saline solution or any other liquid intended to be used with the device.

Code information: Lot Code: UDI-DI: (01) 10815611020012 UDI-PI: (10) 4303 Lot numbers: 4303-1, 4303-2, 4303-3

Distribution pattern: US Nationwide distribution in the states of Indiana, Tennessee, New York, Minnesota, New Jersey, Ohio, Kentucky, Illinois, and South Dakota.