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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