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

Recall date

July 12, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2550-2016

FDA classification

Class II

Brand / firm

Resmed Corporation

Sold / distributed

US nationwide distribution

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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