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Open, Classified

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

FDA Recall Z-1544-2024 · Posted 2024-04-15

Recalling FirmUnomedical A/S
Recall StatusOpen, Classified
Product CodeFPA
Date Initiated2024-03-05
Product Quantity10,770 units

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.

Firm 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.

Root Cause

Device Design

Distribution Pattern

US Nationwide distribution in the state of Florida.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K162812Unomedical 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 SetUnomedical A/S · 2017-11-01

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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