FDA-Device2024-04-24Class II
Neria Soft Infusion Set, Product Code 507302, intravascular administration set
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.
Sold states
US Nationwide distribution in the state of Florida.
Affected count
10,770 units
Manufactured in
Osted, Aholmvej 1 - 3, Lejre, Denmark
Products
Neria Soft Infusion Set, Product Code 507302, intravascular administration set
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1544-2024Don't want to check this manually?
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