Events

Recall of Device Recall Quattro Air full face mask (FFM)

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Resmed Corporation.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    74736
  • Event Risk Class
    Class 2
  • Event Number
    Z-2550-2016
  • Event Initiated Date
    2016-07-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-09-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148349
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Ventilator, non-continuous (respirator) - Product Code BZD
  • 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.
  • 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.

Device

Device Recall Quattro Air full face mask (FFM)
  • Model / Serial
    Lot 1142623
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US nationwide distribution
  • Product Description
    Quattro Air FFM MED  AMER, Product Code: 62702, full face mask for use with active-exhaust-valve ventilators
  • Manufacturer
    Resmed Corporation

Manufacturer

Resmed Corporation
  • Manufacturer Address
    Resmed Corporation, 9001 Spectrum Center Blvd, San Diego CA 92123-1438
  • Manufacturer Parent Company (2017)
    ResMed, Inc.
  • Source
    USFDA