Class II U.S. Food and Drug Administration

Mozarc Medical US LLC Mahurkar" Acute High Pressure Triple Lumen Catheter Tray recall: A potential issue with the seal integrity of header bag packaging

Recall published 12 months ago

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

The hazard: Device safety concern

A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

What the notice says: A potential issue with the seal integrity of header bag packaging.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-0426-2026
Published
November 12, 2025
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Mozarc Medical US LLC
Product type
Medical devices
Units affected
3,258 units
Distribution
Nationwide
Made in
United States
Lot / code info
REF Number: 8888104004HP; UDI-DI: (Individual unit) 10884521832817, (Carton) 20884521128061; Lot number: 2427800166;
UPC codes
10884521832817, 20884521128061

Products covered by this recall

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

Check your product

The notice names 4 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 10884521832817
  • 20884521128061

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 2427800166

Model or item number

On the rating label, the box or the instruction sheet.

  • 8888104004HP

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Mozarc Medical US LLC — A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. If you are a facility, quarantine affected stock and log the correction.
  3. Report device problems to the FDA through MedWatch.
  4. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.

Claiming on a recalled device

Device recalls are tracked by serial and lot number, so your claim moves faster if you lead with those.

  • Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.
  • Ask explicitly whether your unit is in the affected range; many recalls cover only part of a model line.
  • If you need the device daily, ask what interim arrangement they offer while the remedy is carried out.
  • Log the date, the name and the reference number of every call. Device recalls can run for months.

Company contact: Mozarc Medical US LLC — 15 Hampshire St, Mansfield, MA, 02048-1113

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Mozarc Medical US LLC medical devices recalled?

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

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 10884521832817, 20884521128061; lot code 2427800166; model number 8888104004HP. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.

Where was the recalled product sold?

It was distributed nationwide.

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