Reported Jan 15, 2025 · Ongoing

Dialyzer Optiflux 160NRe

Fresenius Medical Care Holdings, Inc.

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: Fresenius Medical Care Holdings, Inc. · 920 Winter St Bld 920 · Waltham, MA · 02451-1521

Is this the product you have?

  • Dialyzer Optiflux 160NRe
Lot codes and dates
  • UDI NUMBERS
    • 24HU06011-00840861100149-270630
    • 24HU06010-00840861100149-270630
  • Expiration date06/30/2027
Amount recalled
5,351 cases (64,212 dialyzers)

Where it was sold

  • Nationwide

Why it was recalled

Potential for internal blood leaks due to cracked polyurethane

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, 5:35 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.