Z-2550-2016Class II

Quattro Air FFM MED AMER

Name: Z-2550-2016 Quattro Air FFM MED AMER
Creator: Resmed Corporation
Published: 2016-07-12
License: https://open.fda.gov/license/

ResMed Corp / initiated 2016-07-12 / Terminated / root cause: packaging

FDA source

Resmed Corporation began a recall of Quattro Air FFM MED AMER, Product Code: 62702, full face mask for use with active-exhaust-valve ventilators on 2016-07-12. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2550-2016
Classification: Class II
Status: Terminated
Initiated: 2016-07-12
Posted: 2016-08-16
Terminated: 2016-09-26
Recalling firm: ResMed Corp
Product: Quattro Air FFM MED AMER, Product Code: 62702, full face mask for use with active-exhaust-valve ventilators
Product code: BZD Ventilator, Non-Continuous (Respirator)
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.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: An urgent product recall notification letter was sent to all customers on 7/12/16 to inform them that ResMed is recalling NV Quattro Air & Quattro Air Mask due to a mislabeling Issue. The letter informs the customers that during the investigation of a product complaint, ResMed identified that a small number of masks labelled and sold as 62702 Quattro Air FFM MED AMER, Lot 1142623 actually contain an NV Quattro Air FFM Large mask. The letter informs the customers to notify anyone they may have sold the products to. Customers with any questions are instructed to call the ResMed Customer Service team: 858-836-5968.
Quantity in commerce: 42 units
Distribution: US nationwide distribution
Product codes and lots: Lot 1142623

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2550-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2550-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-24	2016-08-16

Product code BZD

K123979Class IIQuattro AirResmed, Ltd. / cleared 2013-02-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)