Neria Soft Infusion Set, Product Code 507302, intravascular administration set

FDA device recall Z-1544-2024 · posted 2024-04-15 · Open, Classified

Recall details

Recalling firm: Unomedical A/S
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.
Action taken: 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.
Root cause: Device Design
Status: Open, Classified
Product code: FPA
Quantity affected: 10,770 units
Distribution: US Nationwide distribution in the state of Florida.
Date initiated: 2024-03-05
Date posted: 2024-04-15
Location: Lejre, Denmark

Recalls and clearances share one API, with change alerts when new recalls post.

Record	Firm	Date
Unomedical Comfort Subcutaneous Infusion Set, Unomedical Comfort Short Subcutaneous Infusion Set, Unomedical Neria Soft Subcutaneous Infusion Set, Medtronic Silhouette Subcutaneous Infusion Set, Medtronic Silhouette Paradigm Subcutaneous Infusion Set, Roche Accu-Chek Tender Subcutaneous Infusion Set, Asante Comfort Subcutaneous Infusion Set, Abbott Comfort Subcutaneous Infusion Set (K162812)	Unomedical A/S	2017-11-01