Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Neria Soft Infusion Set Recalled by Unomedical A/S Due to Specific lots of Neria Soft Infusion Sets, which...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Unomedical A/S directly.
Affected Products
Neria Soft Infusion Set, Product Code 507302, intravascular administration set
Quantity: 10,770 units
Why Was This Recalled?
Specific lots of Neria Soft Infusion Sets, which have been shipped into the US Market, have been shipped with the incorrect Instruction for Use (IFU) within the final pack. The IFU included is the IFU registered for the Rest of World (ROW) countries. The difference between the US IFU and the ROW IFU is the addition of an intended use section in the ROW IFU.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Unomedical A/S
Unomedical A/S has 6 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report