Iontophoresis Patch Therapy Device Recalled for Non-Absorbing Pads
LTS Therapy Systems is recalling IontoPatch STAT transdermal patches because the nonwoven pads fail to absorb saline solution, preventing the device from functioning as intended.
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: FDA Class II medical device recall involving a functional defect that prevents the device from delivering therapy as designed. Per the rubric, Class II recalls with no reported illnesses or injuries and a theoretical hazard are scored at most 3.
Plain-English summary
LTS Therapy Systems, LLC is recalling IontoPatch STAT, On-the-Go Patch Therapy, Model/Catalog Number D-0062-080 due to a defect in the nonwoven pads. The pads do not absorb the saline solution or other liquids intended to be used with the device.
IontoPatch STAT is an iontophoresis transdermal patch designed to deliver medication through the skin using electrical current. When the pads fail to absorb the required saline solution, the device cannot function properly, preventing patients from receiving their intended therapy.
Approximately 80,928 units were distributed nationwide to Indiana, Tennessee, New York, Minnesota, New Jersey, Ohio, Kentucky, Illinois, and South Dakota. Affected devices carry lot numbers 4283-1, 4283-2, 4283-3, and 4283-4 (UDI-DI: 10815611020005, UDI-PI: 4283).
Consumers should stop using affected units and contact LTS Therapy Systems or their healthcare provider for information on replacement or repair options. No illnesses or injuries have been reported.
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
- device-malfunction
- inadequate-absorbency
- therapy-failure
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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