Unomedical A/S: Neria Soft Infusion Set, Product Code 507302, intravascular administration set

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.

Details from the source

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: US Nationwide distribution in the state of Florida. Quantity: 10,770 units Lot/code info: UDI/DI 05705244001558, Lot Numbers: 5277396, 5371146

UPC codes

05705244001558

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.