Neria Soft Infusion Set recall
Neria Soft Infusion Set, Product Code 507302, intravascular administration set
Why was Neria Soft Infusion Set 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI/DI 05705244001558, Lot Numbers: 5277396, 5371146
- Product
- Neria Soft Infusion Set, Product Code 507302, intravascular administration set
- Recalling firm
- Unomedical A/S
- Quantity
- 10,770 units
- Distribution
- US Nationwide distribution in the state of Florida.
- Recall date
- April 24, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)