Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1544-2024 — Neria Soft Infusion Set, Product Code 507302, intravascular administration set

U.S. FDA — Device Enforcement · Denmark · 2024-03-05 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1544-2024
Date of alert
2024-03-05
Country / jurisdiction
Denmark
Risk level
Class II
Risk type
recall
Brand
Unomedical A/S
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
05705244001558
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.