Neria Soft Infusion Set, Product Code 507302, intravascular administration set
Reported: April 24, 2024 Initiated: March 5, 2024 #Z-1544-2024
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.
Details
- Recalling Firm
- Unomedical A/S
- Units Affected
- 10,770 units
- Distribution
- US Nationwide distribution in the state of Florida.
- Location
- Lejre
Frequently Asked Questions
What product was recalled? ▼
Neria Soft Infusion Set, Product Code 507302, intravascular administration set. Recalled by Unomedical A/S. Units affected: 10,770 units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 24, 2024. Severity: Moderate. Recall number: Z-1544-2024.
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