Unomedical A/S Recall 94217
Description: Neria Soft Infusion Set, Product Code 507302, intravascular administration set
Unomedical A/S Recall 94217 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1544-2024 |
| Event ID | 94217 |
| Event Description | Neria Soft Infusion Set, Product Code 507302, intravascular administration set |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the state of Florida. |
| Quantity | 10,770 units |
| Recall 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. |
| Device Classification | 20240424 |
| Device Code Info | UDI/DI 05705244001558, Lot Numbers: 5277396, 5371146 |
| Center Classification Date | 20240415 |
| Recall Initiation Date | 20240305 |
| Recalling Firm | Unomedical A/S |
| Initial Notification | |
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