Z-1544-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- April 24, 2024
- Initiation Date
- March 5, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10,770 units
Product Description
Neria Soft Infusion Set, Product Code 507302, intravascular administration set
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 Pattern
US Nationwide distribution in the state of Florida.
Code Information
UDI/DI 05705244001558, Lot Numbers: 5277396, 5371146