Neria Soft Infusion Set (Unomedical) – Incorrect Instructions (2024)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Neria Soft Infusion Set, Product Code 507302, intravascular administration set
Brand
Unomedical A/S Osted Aholmvej 1
Lot Codes / Batch Numbers
UDI/DI 05705244001558, Lot Numbers: 5277396, 5371146
Products Sold
UDI/DI 05705244001558, Lot Numbers: 5277396, 5371146
Unomedical A/S Osted Aholmvej 1 is recalling Neria Soft Infusion Set, Product Code 507302, intravascular administration set due to 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) . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Unomedical a/s issued an URGENT: VOLUNTARY MEDICAL DEVICE RECALL notice to its sole consignee on 03/05/2024 via email. The notice explained the issue and requested they examine their inventory for affected product and quarantine it pending destruction. The consignee was also directed to notify their customers.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026