FDA-Device2016-08-24Class II
Quattro Air FFM MED AMER, Product Code: 62702, full face mask for use with active-exhaust-valve ventilators
Resmed Corporation
Hazard
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.
Sold states
US nationwide distribution
Affected count
42 units
Manufactured in
9001 Spectrum Center Blvd, N/A, San Diego, CA, United States
Products
Quattro Air FFM MED AMER, Product Code: 62702, full face mask for use with active-exhaust-valve ventilators
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2550-2016Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief