FDA Medical Device Recalls (openFDA)
Unomedical A/S: Neria Soft Infusion Set, Product Code 507302, intravascular administration set
- Recall number
- Z-1544-2024
- Recalling firm
- Unomedical A/S
- Product
- Neria Soft Infusion Set, Product Code 507302, intravascular administration set
- Status
- Open, Classified
- Initiated
- 2024-03-05
- Posted
- 2024-04-15
- Terminated
- not on file
- 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.
- Lot, serial or model codes
- UDI/DI 05705244001558, Lot Numbers: 5277396, 5371146
- 510(k) numbers
- ["K162812"]
- PMA numbers
- not on file
- Product code
- FPA
- Firm FEI
- 1000477110
- Firm city
- Lejre
- Firm state
- not on file
- Firm country
- Denmark
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28