Reported Jun 14, 2023 · Terminated

SMMT ambIT Kit Basic Filter Luer Cass, Product Code: 220537

Avanos Medical, 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: Avanos Medical, Inc. · 5405 Windward Pkwy · Alpharetta, GA · 30004-3894

Is this the product you have?

  • SMMT ambIT Kit Basic Filter Luer Cass
  • Product Code220537
Lot codes and dates
  • Lot Number (Expiration Date)
    • 30195563 (17 Jan 2025)
    • 30190578 (17 Jan 2025)
Amount recalled
45 cases (225 cassettes)

This recall covers 5 products

The agency filed one notice per product. You are reading one of them; the other 4 are below.

Where it was sold

Why it was recalled

Some of the ambIT kits were potentially distributed without an air in-line filter.

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

Notice updated Aug 2, 2024 · Data as of Sep 19, 7:00 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.