FDA Device recall Z-1544-2024
Neria Soft Infusion Set, Product Code 507302, intravascular administration set
- FDA Device
- Class II
- ongoing
- Published 2024-04-24
On 2024-04-24 the FDA classified a Class II recall of Neria Soft Infusion Set, Product Code 507302, intravascular administration set by Unomedical A S, citing 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 IF….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1544-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-03-05 |
| Published | 2024-04-24 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Unomedical A S |
| Distribution | US |
Product
Neria Soft Infusion Set, Product Code 507302, intravascular administration set
Reason
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.
Identifiers
| code_info | UDI/DI 05705244001558, Lot Numbers: 5277396, 5371146 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1544-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.