Reported Aug 24, 2016 · Terminated

Quattro Air FFM MED  AMER, Product Code: 62702, full face mask for use with active-exhaust-valve ventilators

Resmed Corporation

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: Resmed Corporation · 9001 Spectrum Center Blvd · San Diego, CA · 92123-1438

Is this the product you have?

  • Quattro Air FFM MED  AMER
  • Product Code62702, full face mask for use with active-exhaust-valve ventilators
Lot codes and dates
  • Lot 1142623
Amount recalled
42 units

Where it was sold

  • Nationwide

Why it was recalled

Masks in this lot, labelled and sold as 62702 vented Quattro Air FFM size Medium actually contain a non-vented (NV) Quattro Air FFM Large mask.

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 Sep 26, 2016 · Data as of Sep 19, 6:02 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.