Events

Recall of Device Recall OxySure Model 615 disposable replacement cartridges

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

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
    71524
  • Event Risk Class
    Class 2
  • Event Number
    Z-2253-2015
  • Event Initiated Date
    2015-06-12
  • Event Date Posted
    2015-07-24
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138103
  • 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
    Generator, oxygen, portable - Product Code CAW
  • Reason
    Flow rate of the recalled replacement cartridges does not meet the draft fda standard of a minimum 6 lpm for a minimum of 15 minutes.
  • Action
    The recalling firm will notify their affected customers via email beginning the week of 6/15/15. The recall notification will have a response for to be completed by the consignee. The recall notification calls for the customers to dispose of the affected product according to the MSDS.

Device

Device Recall OxySure Model 615 disposable replacement cartridges
  • Model / Serial
    lots 61-65
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide throughout the US and Chile, Trinidad, China
  • Product Description
    OxySure Model 615 disposable replacement cartridges, for portable oxygen generator.
  • Manufacturer
    Oxysure Systems, Inc.

Manufacturer

Oxysure Systems, Inc.
  • Manufacturer Address
    Oxysure Systems, Inc., 10880 John W Elliott Dr Ste 600, Frisco TX 75033-3281
  • Source
    USFDA