MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12...
FDA Recall #Z-0421-2026 — Class II — October 17, 2025
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.
Recalling Firm
Mozarc Medical US LLC — Mansfield, MA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
3,258 units
Distribution
US Nationwide distribution.
Code Information
REF Number: 8888101001HP; UDI-DI: (Individual unit) 10884521127890, (Carton) 20884521127897; Lot number: 2430500021
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated