Unomedical A/S: Medical Device Recall in 2024 - (Recall #: Z-1544-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: March 5, 2024

Date Posted: April 24, 2024

Recall Number: Z-1544-2024

Event ID: 94217

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.

Status: Ongoing

Product Quantity: 10,770 units

Code Information:

UDI/DI 05705244001558, Lot Numbers: 5277396, 5371146

Distribution Pattern:

US Nationwide distribution in the state of Florida.

Voluntary or Mandated:

Voluntary: Firm initiated