[pending] IontoPatch 80, On-the-Go Patch Therapy, Model/Catalog Number: D-0077-080; The IontoPatch is an Ion
Pending LLM rewrite. Source: FDA_DEVICE Z-2197-2025.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
The nonwoven pads in the device do not absorb the saline solution or any other liquid intended to be used with the device.
The recalled product
- Product
- IontoPatch 80, On-the-Go Patch Therapy, Model/Catalog Number: D-0077-080; The IontoPatch is an Iontophoresis transdermal patch.
- Manufacturer
- LTS Therapy Systems, LLC
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot Code: UDI-DI: (01) 10815611020012 UDI-PI: (10) 4303 Lot numbers: 4303-1
- 4303-2
- 4303-3
Distribution
Distributed nationwide across the United States.
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