Neria Soft Infusion Set — Class II medical device recall Z-1544-2024
Ongoing recall by Unomedical A/S, reported 2024-04-24, distributed nationwide. Specific lots of Neria Soft Infusion Sets, which have been shipped into the US Market, have been shipped with
| Recall number | Z-1544-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Unomedical A/S, Lejre, Denmark |
| Recall initiated | 2024-03-05 |
| Classified | 2024-04-15 |
| Reported by FDA | 2024-04-24 |
| Distributed | Nationwide (US) |
| Quantity | 10,770 units |
| UPC / GTIN / UDI-DI | 05705244001558 |
| Lot numbers | 5277396, 5371146 |
Product
Neria Soft Infusion Set, Product Code 507302, intravascular administration set
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1544-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.