FDAClass IINovember 12, 2025

MAHURKAR" Acute High Pressure Triple Lumen Catheter recall

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

Why was MAHURKAR" Acute High Pressure Triple Lumen Catheter recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

REF Number: 8888101001HP; UDI-DI: (Individual unit) 10884521127890, (Carton) 20884521127897; Lot number: 2430500021

Product
MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 13 cm;
Recalling firm
Mozarc Medical US LLC
Quantity
3,258 units
Distribution
US Nationwide distribution.
Recall date
November 12, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls