FDA recall Z-2196-2025

LTS Therapy Systems, LLC · Class II · device

Product

IontoPatch STAT, On-the-Go Patch Therapy, Model/Catalog Number D-0062-080; IontoPatch is an Iontophoresis transdermal patch.

Reason for recall

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

Distribution

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

Key facts

Status
Ongoing
Initiation date
2025-05-22
Report date
2025-08-06
Voluntary/Mandated
Voluntary: Firm initiated
Location
Saint Paul, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2196-2025