Drug recall
Neria Soft Infusion Set, Product Code 507302, intravascular administration set
FDA recall event 94217 · Class II · Unomedical A/S
Key facts
| Event ID | 94217 |
|---|---|
| Recall numbers | Z-1544-2024 |
| Recalling firm | Unomedical A/S |
| Product type | Devices |
| Products | Neria Soft Infusion Set, Product Code 507302, intravascular administration set |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Mar 5, 2024 |
| Report date | Apr 24, 2024 |
| City | Lejre |
| Country | Denmark |
| FEI number | 1000477110 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: