IontoPatch STAT nonwoven pads do not absorb the saline solution
IontoPatch STAT On-the-Go Patch Therapy is being recalled because the nonwoven pads in the device do not absorb the saline solution or any other liquid intended to be used with it. 80,928 units affected.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall where the device does not function as intended, with no incorrect treatment or patient hazard stated in the source.
Plain-English summary
IontoPatch STAT, On-the-Go Patch Therapy, model number D-0062-080, an iontophoresis transdermal patch, UDI-DI 10815611020005, is being recalled. The action covers 80,928 units across the lot numbers listed in the recall notice, including 4283-1, 4283-2 and 4283-3.
The stated reason is that the nonwoven pads in the device do not absorb the saline solution or any other liquid intended to be used with the device. The FDA classified the action as Class II. The source does not describe a resulting clinical consequence.
Distribution was nationwide in the United States, including Indiana, Tennessee, New York and Minnesota among other states.
Facilities should identify affected stock using the model number, UDI-DI and lot numbers above and follow the instructions issued by the manufacturer.
The recalled product
- Product
- IontoPatch STAT, On-the-Go Patch Therapy, Model/Catalog Number D-0062-080; IontoPatch is an Iontophoresis transdermal patch.
- Manufacturer
- LTS Therapy Systems, LLC
- Hazard
- pad-absorption-failure
- device-nonfunction
- class-ii
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 (4)
- Lot Code: UDI-DI: (01) 10815611020005 UDI-PI: (10) 4283 Lot numbers: 4283-1
- 4283-2
- 4283-3
- 4283-4
Distribution
Distributed nationwide across the United States.
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