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FDAFDA · Food and drugs·Recall number Z-2550-2016

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

Published August 24, 2016 · Recall initiated: July 12, 2016

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the 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.

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
Resmed Corporation
Distributor
US nationwide distribution
Lot
Lot 1142623
Risk classification
Class II
Area (FDA)
device
Country
United States

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