PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: November 12, 2025 Initiated: October 17, 2025 #Z-0424-2026

Product Description

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

Reason for Recall

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

Details

Recalling Firm
Mozarc Medical US LLC
Units Affected
3,258 units
Distribution
US Nationwide distribution.
Location
Mansfield, MA

Frequently Asked Questions

What product was recalled?
MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 20 cm;. Recalled by Mozarc Medical US LLC. Units affected: 3,258 units.
Why was this product recalled?
A potential issue with the seal integrity of header bag packaging.
Which agency issued this recall?
This recall was issued by the FDA Devices on November 12, 2025. Severity: Moderate. Recall number: Z-0424-2026.