Neria Soft Infusion Set, Product Code 507302, intravascular administration set
This recall is currently active, issued April 15, 2024. It was issued by Unomedical A/S Osted Aholmvej 1.
- Company
- Unomedical A/S Osted Aholmvej 1
- Recall Initiated
- March 5, 2024
- Posted
- April 15, 2024
- Recall Number
- Z-1544-2024
- Quantity
- 10,770 units
- Official Source
- View on FDA website ↗
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.
Lot / Code Info
UDI/DI 05705244001558, Lot Numbers: 5277396, 5371146
Root Cause
Device Design
Action Taken
Unomedical a/s issued an URGENT: VOLUNTARY MEDICAL DEVICE RECALL notice to its sole consignee on 03/05/2024 via email. The notice explained the issue and requested they examine their inventory for affected product and quarantine it pending destruction. The consignee was also directed to notify their customers.