Medical device recalls Moderate risk

Mozarc Medical US LLC recalls MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 20…

Recall date
October 17, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0424-2026
FDA classification
Class II
Brand / firm
Mozarc Medical US LLC
Sold / distributed
US Nationwide distribution.

Why it was recalled

A potential issue with the seal integrity of header bag packaging.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 20 cm;

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