Reported Nov 12, 2025 · Ongoing

MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Safety Components: 12 Fr/Ch (4.0…

Mozarc Medical US LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Mozarc Medical US LLC · 15 Hampshire St · Mansfield, MA · 02048-1113

Is this the product you have?

  • MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight
  • Extensions with IC Safety Components12 Fr/Ch (4.0 mm) x 24 cm
Lot codes and dates
  • REF Number8888104004HP
  • UDI-DI
    • (Individual unit) 10884521832817
    • (Carton) 20884521128061
  • Lot number2427800166
Amount recalled
3,258 units

This recall covers 6 products

The agency filed one notice per product. You are reading one of them; the other 5 are below.

Where it was sold

  • Nationwide

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 4:54 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.