Device product
IontoPatch STAT, On-the-Go Patch Therapy, Model/Catalog Number D-0062-080; IontoPatch is an Iontophoresis transdermal patch.
Z-2196-2025
Product summary
- Event
- Event 97146
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 80928 units
- Official record key
device-enforcement:Z-2196-2025
Official wording
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) 10815611020005 UDI-PI: (10) 4283 Lot numbers: 4283-1, 4283-2, 4283-3, 4283-4
Distribution pattern: US Nationwide distribution in the states of Indiana, Tennessee, New York, Minnesota, New Jersey, Ohio, Kentucky, Illinois, and South Dakota.
Derived failure modes
-
Unknown
The nonwoven pads in the device do not absorb the saline solution or any other liquid intended to be used with the device.