Recall Z-1544-2024— Unomedical A/S

Name: FDA recall Z-1544-2024
Creator: U.S. Food and Drug Administration
Published: 2024-03-05

Class II · Ongoing

Class II FDA medical device recall by Unomedical A/S, initiated 2024-03-05. It names one FDA 510(k) clearance: K162812. Product: Neria Soft Infusion Set, Product Code 507302, intravascular administration set. 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..

Recalling firm: Unomedical A/S
Classification: Class II
Status: Ongoing
Initiated: 2024-03-05
Firm location: Lejre, Denmark

510(k) clearances named in this recall

1 on FDA's record

K162812 — 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 SetUnomedical A/S·cleared 2017-11-01

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.