Z-0425-2026 Class II Ongoing

Recalled by Mozarc Medical US LLC — Mansfield, MA

Recall Details

Product Type
Devices
Report Date
November 12, 2025
Initiation Date
October 17, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
3,258 units

Product Description

MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC 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 Pattern

US Nationwide distribution.

Code Information

REF Number: 8888102004HP; UDI-DI: (Individual unit) 10884521128002, (Carton) 20884521128009; Lot number: 2424500197;