Z-1544-2024Class II

Neria Soft Infusion Set, Product Code 507302, intravascular administration set

Name: Z-1544-2024 Neria Soft Infusion Set, Product Code 507302, intravascular administration set
Creator: Unomedical A/S
Published: 2024-03-05
License: https://open.fda.gov/license/

Unomedical A/S / initiated 2024-03-05 / Open, Classified / root cause: design

FDA source

Unomedical A/S began a recall of Neria Soft Infusion Set, Product Code 507302, intravascular administration set on 2024-03-05. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1544-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-03-05
Posted: 2024-04-15
Recalling firm: Unomedical A/S
Product: Neria Soft Infusion Set, Product Code 507302, intravascular administration set
Product code: FPA Set, Administration, Intravascular
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.
Root cause tag: design
FDA root cause: Device Design
Action: 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.
Quantity in commerce: 10,770 units
Distribution: US Nationwide distribution in the state of Florida.
Product codes and lots: UDI/DI 05705244001558, Lot Numbers: 5277396, 5371146

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1544-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1544-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-04-24	2024-04-15

Product code FPA

K162812Class IIUnomedical Comfort Subcutaneous Infusion Set, Unomedical Comfort Short Subcutaneous Infusion Set, Unomedical Neria Soft Subcutaneous Infusion Set, Medtronic Silhouette Subcutaneous Infusion Set, Medtronic Silhouette Paradigm Subcutaneous Infusion Set, Roche Accu-Chek Tender Subcutaneous Infusion Set, Asante Comfort Subcutaneous Infusion Set, Abbott Comfort Subcutaneous Infusion SetUnomedical A/S / cleared 2017-11-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)