FDAFDA · Food and drugs·Recall number Z-1544-2024
Neria Soft Infusion Set, Product Code 507302, intravascular administration set
Published April 24, 2024 · Recall initiated: March 5, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Unomedical A/S
- Distributor
- US Nationwide distribution in the state of Florida.
- Lot
- UDI/DI 05705244001558, Lot Numbers: 5277396, 5371146
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Denmark
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