Recall Z-2550-2016— Resmed Corporation

Name: FDA recall Z-2550-2016
Creator: U.S. Food and Drug Administration
Published: 2016-07-12

Class II · Terminated

Class II FDA medical device recall by Resmed Corporation, initiated 2016-07-12, terminated 2016-09-26. It names one FDA 510(k) clearance: K123979. Product: Quattro Air FFM MED AMER, Product Code: 62702, full face mask for use with active-exhaust-valve ventilators. 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..

Recalling firm: Resmed Corporation
Classification: Class II
Status: Terminated
Initiated: 2016-07-12
Terminated: 2016-09-26
Firm location: San Diego, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K123979 — QUATTRO AIRResmed, Ltd.·cleared 2013-02-27

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.