Device product

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

Z-2550-2016

July 12, 2016

Class II

Product summary

Firm: Resmed Corporation
Event: Event 74736
Status: Terminated
Classification: Class II
Quantity: 42 units
Official record key: device-enforcement:Z-2550-2016

Official wording

Reason: 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.

Code information: Lot 1142623

Distribution pattern: US nationwide distribution

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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.