Medical Device Recall: Neria Soft Infusion Set, Product Code 507302, intravascular administration set
Unomedical A/S · March 5, 2024
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.
States Affected
NATIONWIDE
Quantity Affected
10,770 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1544-2024
Status: ongoing
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