LTS Therapy Systems recalls IontoPatch STAT patches (model D-0062-080) due to nonwoven pads failing to absorb saline solution, risking ineffective treatment. Affected units include specific lot numbers.
The nonwoven pads in the device do not absorb the saline solution or any other liquid intended to be used with the device.
LTS Therapy Systems is recalling IontoPatch STAT patches because the nonwoven pads don't absorb saline solution. This could lead to ineffective treatment as the patches are designed to deliver medication through the skin.
The nonwoven pads in the device do not absorb the saline solution or any other liquid intended for use. This means the patches may not deliver medication effectively, potentially leading to treatment failure.
Users of IontoPatch STAT patches for medical treatment are affected. Those with specific lot numbers (4283-1 to 4283-4) are most at risk.
Check for the model number D-0062-080 on the patch. Affected units have lot numbers 4283-1 through 4283-4.
Look for the model number D-0062-080 on the patch.
Check if your patch has lot numbers 4283-1, 4283-2, 4283-3, or 4283-4.
The nonwoven pads in the device do not absorb the saline solution or any other liquid intended for use, which could lead to ineffective treatment.
Check the model number and lot numbers to see if your patch is affected. If it is, contact LTS Therapy Systems for further instructions.
The patches may not deliver medication effectively, but there is no immediate risk of injury or harm to users.
We’ve drafted a message you can send LTS Therapy Systems to request your refund or repair — edit it as you like.
Subject: Recall Z-2196-2025 — LTS Therapy Systems LTS Therapy Systems Hello, I own a LTS Therapy Systems that is covered by recall Z-2196-2025 from LTS Therapy Systems. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.