Z-2196-2025 Class II Ongoing
FDA device recall Z-2196-2025 was initiated by LTS Therapy Systems, LLC on May 22, 2025 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 80928 units.
Recall Details
- Product Type
- Devices
- Report Date
- August 6, 2025
- Initiation Date
- May 22, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 80928 units
Product Description
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 Pattern
US Nationwide distribution in the states of Indiana, Tennessee, New York, Minnesota, New Jersey, Ohio, Kentucky, Illinois, and South Dakota.
Code Information
Lot Code: UDI-DI: (01) 10815611020005 UDI-PI: (10) 4283 Lot numbers: 4283-1, 4283-2, 4283-3, 4283-4