Neria Soft Infusion Set, Product Code 507302, intravascular… recallZ-1544-2024 · Unomedical A/S · initiated Mar 5, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Unomedical A/S or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Device Design
What the company is doing
Unomedical a/s issued an URGENT: VOLUNTARY MEDICAL DEVICE RECALL notice to its sole consignee on 03/05/2024 via email. The notice explained the issue and requested they examine their inventory for affected product and quarantine it pending destruction. The consignee was also directed to notify their customers.
Recall details
- Recall number
- Z-1544-2024
- Status
- Open, Classified
- Initiated by the company
- Mar 5, 2024
- Posted by the FDA
- Apr 15, 2024
- Recalling firm
- Unomedical A/S
- Quantity
- 10,770 units
- Product code
- FPA
- FDA submissions
- K162812
- Distribution
- US Nationwide distribution in the state of Florida.
Product description
Neria Soft Infusion Set, Product Code 507302, intravascular administration set
Code information (models, lots, serial numbers)
UDI/DI 05705244001558, Lot Numbers: 5277396, 5371146
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- neria™soft 79-080-2622Unomedical A/S · Set, Administration, Intravascular1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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