FDA Medical Device Recalls (openFDA)
Resmed Corporation: Quattro Air FFM MED AMER, Product Code: 62702, full face mask for use with active-exhaust-valve ventilators
- Recall number
- Z-2550-2016
- Recalling firm
- Resmed Corporation
- Product
- Quattro Air FFM MED AMER, Product Code: 62702, full face mask for use with active-exhaust-valve ventilators
- Status
- Terminated
- Initiated
- 2016-07-12
- Posted
- not on file
- Terminated
- 2016-09-26
- 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.
- 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
- 42 units
- Distribution
- US nationwide distribution
- Lot, serial or model codes
- Lot 1142623
- 510(k) numbers
- ["K123979"]
- PMA numbers
- not on file
- Product code
- BZD
- Firm FEI
- 1000115734
- Firm city
- San Diego
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28