Official recall record
Neria Soft Infusion Set, Product Code 507302, intravascular administration set
- Issuing authority
- US FDA — Medical Devices
- Alert date
- 2024-03-05
- Country of alert
- Denmark
- Alert level
- Class II
- Alert type
- recall
- Barcode (EAN/GTIN)
- 05705244001558
- Brand on record
- Unomedical A/S
What the authority reported
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.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
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