FDAHealthMay 22, 2025
LTS Therapy Systems, LLC — IontoPatch 80, On-the-Go Patch Therapy, Model/Catalog Number: D-0077-080; The IontoPatch is an Iontophoresis transdermal patch.
⚠️ The nonwoven pads in the device do not absorb the saline solution or any other liquid intended to be used with the device.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- May 22, 2025
US Nationwide distribution in the states of Indiana, Tennessee, New York, Minnesota, New Jersey, Ohio, Kentucky, Illinois, and South Dakota.
What's affected?
- Product
- IontoPatch 80, On-the-Go Patch Therapy, Model/Catalog Number: D-0077-080; The IontoPatch is an Iontophoresis transdermal patch.
- Lot code
- UDI-DI:
Additional details
Lot Code: UDI-DI: (01) 10815611020012 UDI-PI: (10) 4303 Lot numbers: 4303-1, 4303-2, 4303-3
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 63936 units.
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