Recall Z-0421-2026— Mozarc Medical US LLC

Name: FDA recall Z-0421-2026
Creator: U.S. Food and Drug Administration
Published: 2025-10-17

Class II · Ongoing

Class II FDA medical device recall by Mozarc Medical US LLC, initiated 2025-10-17. It names one FDA 510(k) clearance: K192302. Product: MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 13 cm;. Reason: A potential issue with the seal integrity of header bag packaging..

Recalling firm: Mozarc Medical US LLC
Classification: Class II
Status: Ongoing
Initiated: 2025-10-17
Firm location: Mansfield, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K192302 — Mahurkar Acute Single Lumen Catheter, Mahurkar Acute Dual Lumen Catheter, Mahurkar Acute Triple Lumen Catheter, Mahurkar Acute High Pressure Triple Lumen CatheterCovidien, LLC·cleared 2020-01-17

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

MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 13 cm;

Reason for recall

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

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