# FDA recall Z-1544-2024

> **Unomedical A/S** · Class II · device recall initiated 2024-03-05.

## 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.

## Distribution

US Nationwide distribution in the state of Florida.

## Key facts

- **Recall number:** Z-1544-2024
- **Recalling firm:** Unomedical A/S
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-03-05
- **Report date:** 2024-04-24

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Lejre, Denmark

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1544-2024

## Citation

> AI Analytics. FDA recall Z-1544-2024. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1544-2024. Source: US FDA. Licensed CC0.

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