Recall Z-1544-2024 ยท FPA Set, Administration, Intravascular
Unomedical A/S
Neria Soft Infusion Set, Product Code 507302, intravascular administration set
| Date | Apr 15, 2024 (initiated Mar 5, 2024) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Device Design |
| Action | 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. |
| Quantity | 10,770 units |
| Distribution | US Nationwide distribution in the state of Florida. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K162812 | Unomedical Comfort Subcutaneous Infusion Set, Unomedical Comfort Short Subcutaneous Infusion Set, Unomedical Neria Soft Unomedical A/S, Nov 1, 2017 |