Z-1544-2024 Class II Ongoing
FDA device recall Z-1544-2024 was initiated by Unomedical A/S on Mar 5, 2024 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 10,770 units.
Recall details
- Product Type
- Devices
- Report Date
- Apr 24, 2024
- Initiation Date
- Mar 5, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10,770 units
Product description
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 pattern
US Nationwide distribution in the state of Florida.
Code information
UDI/DI 05705244001558, Lot Numbers: 5277396, 5371146
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1544-2024
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026