Home / Recalls / Medical Devices
Unomedical A/S recalls Neria Soft Infusion Set, Product Code 507302, intravascular administration set
Recalled April 24, 2024 · FDA recall Z-1544-2024 · Unomedical A/S
Hazard
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 Class II
Units
10,770 units
Sold at
US Nationwide distribution in the state of Florida.
Description
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.
Product
Neria Soft Infusion Set, Product Code 507302, intravascular administration set
Manufacturer(s)
Unomedical A/S
Made in
Denmark
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →