FDA recall Z-0426-2026

Mozarc Medical US LLC · Class II · device

Product

MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Safety Components: 12 Fr/Ch (4.0 mm) x 24 cm;

Reason for recall

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

Distribution

US Nationwide distribution.

Key facts

Status
Ongoing
Initiation date
2025-10-17
Report date
2025-11-12
Voluntary/Mandated
Voluntary: Firm initiated
Location
Mansfield, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0426-2026