Reported Apr 24, 2024 · Ongoing
Neria Soft Infusion Set, Product Code 507302, intravascular administration set
Unomedical A/S
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Unomedical A/S · Osted · Lejre · N/A
Is this the product you have?
- Neria Soft Infusion Set, Product Code 507302, intravascular administration set
- Lot codes and dates
- UDI/DI 05705244001558
- Lot Numbers
52773965371146
- Amount recalled
- 10,770 units
Where it was sold
- Nationwide
- FL
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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