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

Reason: 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.

Code information: UDI/DI 05705244001558, Lot Numbers: 5277396, 5371146

Distribution pattern: US Nationwide distribution in the state of Florida.